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Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molar with reversible pulpitis in 3-6 years old children: a randomized clinical trial

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History
# Registration date Revision Id
4 2024-05-28, 1403/03/08 303464
3 2023-12-19, 1402/09/28 289029
2 2023-07-31, 1402/05/09 273711
1 2023-07-27, 1402/05/05 273117
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  • Protocol summary

    comparative study of the clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and cold ceramic in treating the pulp of mandibular second molars with ireversible pulpitis.
    Comparative study of the clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and cold ceramic in treating the pulp of mandibular second molars with reversible pulpitis.
    بررسی مقایسه ای موفقیت و شکست بالینی و رادیوگرافیک Mineral Trioxide Aggregate (MTA) و cold ceramic در درمان پالپ مولرهای دوم شیری فک پایین با پالپیت برگشت ناپذیر
    بررسی مقایسه ای موفقیت و شکست بالینی و رادیوگرافیک Mineral Trioxide Aggregate (MTA) و cold ceramic در درمان پالپ مولرهای دوم شیری فک پایین با پالپیت برگشت پذیر
    parallel-group, double-blind, randomized, phase 2-3 clinical trial on 50 patients. A table of random numbers was used for randomization.
    Parallel-group, double-blind, randomized, phase 2-3 clinical trial on 50 patients. A table of random numbers was used for randomization.
    کارآزمایی بالینی با گروه های موازی ، دو سویه کور ، تصادفی شده، فاز 2-3 بر روی 50 بیمار. برای تصادفی سازی از جدول اعداد تصادفی استفاده شد.
    کارآزمایی بالینی با گروه های موازی، دو سویه کور، تصادفی شده، فاز 2-3 بر روی 50 بیمار. برای تصادفی سازی از جدول اعداد تصادفی استفاده شد.
    In children who refer to the pediatric dental clinic for treatment of pulp in mandibular second molar teeth with irreversible pulpitis, after initial radiography, pulpotomy treatment is performed with a standard protocol. Pulp chamber seal is done for each patient using Mineral Trioxide Aggregate (MTA) or cold ceramic. then if there are no signs and symptoms of treatment failure, the final restoration is done with Stainless Steel Crown (SSC). Clinical evaluation of treatment results of 3, 6 and 12 months and radiographic evaluations are performed in 6 and 12 month periods. The patient and the evaluator of the treatment results will not know what substance was used to flood the canal in each patient
    In children who refer to the pediatric dental clinic for treatment of pulp in mandibular second molar teeth with reversible pulpitis, after initial radiography, pulpotomy treatment is performed with a standard protocol. Pulp chamber seal is done for each patient using Mineral Trioxide Aggregate (MTA) or cold ceramic. then if there are no signs and symptoms of treatment failure, the final restoration is done with Stainless Steel Crown (SSC). Clinical evaluation of treatment results of 3, 6 and 12 months and radiographic evaluations are performed in 6 and 12 month periods. The patient and the evaluator of the treatment results will not know what substance was used to flood the canal in each patient
    در کودکان که به منظور درمان پالپ در دندان های مولرهای دوم شیری فک پایین با پالپیت برگشت ناپذیر به مطب تخصصی کودکان مراجعه می کنند، پس از تهیه ی رادیوگرافی اولیه، درمان پالپوتومی با پروتکل استاندارد انجام می شود. سیل پالپ چمبر برای هر بیمار با استفاده از Mineral Trioxide Aggregate (MTA) یا cold ceramic انجام می شود. سپس در صورت نبود علائم و نشانه های شکست درمان، ترمیم نهایی با Stainless Steel Crown (SSC) انجام می شود. ارزیابی کلینیکی نتایج درمان 3، 6 و 12 ماه و ارزیابی های رادیوگرافیک در دوره های زمانی 6 و 12 ماهه انجام می شوند. بیمار و ارزیابی کننده نتایج درمان اطلاع نخواهند داشت که در هر بیمار از چه ماده ای جهت سیل کانال استفاده شده است
    در کودکان که به منظور درمان پالپ در دندان های مولرهای دوم شیری فک پایین با پالپیت برگشت پذیر به مطب تخصصی کودکان مراجعه می کنند، پس از تهیه ی رادیوگرافی اولیه، درمان پالپوتومی با پروتکل استاندارد انجام می شود. سیل پالپ چمبر برای هر بیمار با استفاده از Mineral Trioxide Aggregate (MTA) یا cold ceramic انجام می شود. سپس در صورت نبود علائم و نشانه های شکست درمان، ترمیم نهایی با Stainless Steel Crown (SSC) انجام می شود. ارزیابی کلینیکی نتایج درمان 3، 6 و 12 ماه و ارزیابی های رادیوگرافیک در دوره های زمانی 6 و 12 ماهه انجام می شوند. بیمار و ارزیابی کننده نتایج درمان اطلاع نخواهند داشت که در هر بیمار از چه ماده ای جهت سیل کانال استفاده شده است
    patients who do not have any systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex, do not need general anesthesia and sedation, have good individual and family cooperation. deep caries with pulp exposure during caries removal.
    Patients who do not have any systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex, do not need general anesthesia and sedation, have good individual and family cooperation. deep caries with pulp exposure during caries removal.
    مداخله A: پالپ باقی مانده با خمیر (cerkamed medical company poland ) MTA پوشانده میشود. مداخله B: پالپ باقی مانده با خمیر cold ceramic(سرو جاوید مدرس، ایران ) پوشانده می شود.
    مداخله A: پالپ باقی مانده با خمیر (creamed medical company Poland) MTA پوشانده میشود. مداخله B: پالپ باقی مانده با خمیر cold ceramic (سرو جاوید مدرس، ایران) پوشانده می شود.
    the percentage of occurrence of pain; sensitivity to accuracy; swelling; pathological laziness; root lucency; internal or external root analysis; Widening of the Periodontal Ligament (PDL); bone loss; and lamina dura integrity
    The percentage of occurrence of pain; sensitivity to accuracy; swelling; pathological laziness; root lucency; internal or external root analysis; Widening of the Periodontal Ligament (PDL); bone loss; and lamina dura integrity

  • General information

    Typographical mistakes
    According to endodontic and pediatric professors, reversible pupitis is correct term.
    اشتباه تایپی
    طبق نظر اساتید کودکان و اندو، اصطلاح برگشت پذیر درست است
    Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molar with ireversible pulpitis in 3-6 years old children: a randomized clinical trial
    Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molar with reversible pulpitis in 3-6 years old children: a randomized clinical trial
    بررسی مقایسه ای درصد موفقیت و شکست بالینی و رادیوگرافیک (MTA) Mineral Trioxide Aggregate و cold ceramic در درمان پالپ مولرهای دوم شیری فک پایین با پالپیت برگشت ناپذیر در کودکان 3-6 سال
    بررسی مقایسه ای درصد موفقیت و شکست بالینی و رادیوگرافیک (MTA) Mineral Trioxide Aggregate و cold ceramic در درمان پالپ مولرهای دوم شیری فک پایین با پالپیت برگشت پذیر در کودکان 3-6 سال
    Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molar with irreversible pulpitis in 3-6 years old children: a randomized clinical trial
    Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molar with reversible pulpitis in 3-6 years old children: a randomized clinical trial
    بررسی مقایسه ای درصد موفقیت و شکست بالینی و رادیوگرافیک (MTA) Mineral Trioxide Aggregate و cold ceramic در درمان پالپ مولرهای دوم شیری فک پایین با پالپیت برگشت ناپذیر در کودکان 3-6 سال
    بررسی مقایسه ای درصد موفقیت و شکست بالینی و رادیوگرافیک (MTA) Mineral Trioxide Aggregate و cold ceramic در درمان پالپ مولرهای دوم شیری فک پایین با پالپیت برگشت پذیر در کودکان 3-6 سال
    وجود دو سوم طول ریشه از نظر رادیوگرافی؛ و عدم شواهد رادیوگرافیک دژنراسیون پالپ، مانند تحلیل ریشه داخلی یا خارجی، رادیولوسنسی فورکا، تخریب استخوان اینتررادیکولار یا پری اپیکال، سنگ های پالپی(pulp stones).
    شامل بیمارانی که هیچ بیماری سیستمیک مانند بیماری مادرزادی یا روماتیسمی قلبی، سرطان خون، واکنش های آلرژیک به موادی مانند بی حس کننده های موضعی و لاتکس ندارند.
    همکاری فردی و خانوادگی خوبی دارند، ضایعات حفره دار عمیق که پالپ آن ها حین برداشتن پوسیدگی اکسپوز می شود .
    وجود دو سوم طول ریشه از نظر رادیوگرافی؛ و عدم شواهد رادیوگرافیک دژنراسیون پالپ، مانند تحلیل ریشه داخلی یا خارجی، رادیولوسنسی فورکا، تخریب استخوان اینتررادیکولار یا پری اپیکال، سنگ های پالپی (pulp stones).
    شامل بیمارانی که هیچ بیماری سیستمیک مانند بیماری مادرزادی یا روماتیسمی قلبی، سرطان خون، واکنش های آلرژیک به موادی مانند بی حس کننده های موضعی و لاتکس ندارند.
    همکاری فردی و خانوادگی خوبی دارند، ضایعات حفره دار عمیق که پالپ آن ها حین برداشتن پوسیدگی اکسپوز می شود .
    The presence of any clinical and radiographic symptoms indicating pulpal degeneration/physiological analysis of more than 2/3 of the root (imminence of tooth loss)/non-physiological analysis of the root/possibility of proper tooth restoration.
    The presence of any clinical and radiographic symptoms indicating pulpal degeneration or physiological analysis of more than 2/3 of the root (imminence of tooth loss) non-physiological analysis of the root or possibility of proper tooth restoration.
    وجود هرگونه علامت کلینیکی و رادیوگرافی نشان دهنده دژنراسیون پالپی/ تحلیل فیزیولوژیک بیشتر از 2/3 ریشه (قریب الوقوع بودن ریزش دندان)/ تحلیل غیر فیزیولوژیک ریشه/ امکان ترمیم مناسب دندان فراهم نباشد.
    وجود هرگونه علامت کلینیکی و رادیوگرافی نشان دهنده دژنراسیون پالپی یا تحلیل فیزیولوژیک بیشتر از 2/3 ریشه (قریب الوقوع بودن ریزش دندان) تحلیل غیر فیزیولوژیک ریشه یا امکان ترمیم مناسب دندان فراهم نباشد.
    ارزیابی های کلینیکی و رادیوگرافیک توسط شخصی که از نوع ماده مصرفی در هر گروه اطلاعی ندارد انجام می شود. -بیمار از نوع ماده مورد استفاده در هر دندان اطلاعی نخواهند داشت.
    ارزیابی های کلینیکی و رادیوگرافیک توسط شخصی که از نوع ماده مصرفی در هر گروه اطلاعی ندارد انجام می شود. بیمار از نوع ماده مورد استفاده در هر دندان اطلاعی نخواهند داشت.

  • Health conditions studied

    #1
    Mandibular molars irreversible pulpitis
    Mandibular molars reversible pulpitis
    پالپیت برگشت ناپذیر مولر شیری فک پایین
    پالپیت برگشت پذیر مولر شیری فک پایین

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shirin marzoughi
    Full name of responsible person - Persian: شیرین مرزوقی
    Position - English: Assistante professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pajoohesh blvd
    Street address - Persian: بلوار پژوهش
    City - English: ilam
    City - Persian: ایلام
    Province: Ilam
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6967114459
    Phone: +98 84 3222 7134
    Mobile: +98 912 500 7698
    Fax:
    Email: shirin.marzoughi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shirin Marzughi
    Full name of responsible person - Persian: شیرین مرزوقی
    Position - English: Assistante professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pajoohesh blvd
    Street address - Persian: بلوار پژوهش
    City - English: ilam
    City - Persian: ایلام
    Province: Ilam
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6967114459
    Phone: +98 84 3222 7134
    Mobile: +98 912 500 7698
    Fax:
    Email: shirin.marzoughi@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shirin marzoughi
    Full name of responsible person - Persian: شیرین مرزوقی
    Position - English: Assistant profesor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: pajoohesh blvd
    Street address - Persian: بلوار پژوهش
    City - English: ilam
    City - Persian: ایلام
    Province: Ilam
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6967114459
    Phone: +98 84 3222 7134
    Mobile: +98 912 500 7698
    Fax:
    Email: shirin.marzoughi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shirin Marzughi
    Full name of responsible person - Persian: شیرین مرزوقی
    Position - English: Assistant profesor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pajoohesh blvd
    Street address - Persian: بلوار پژوهش
    City - English: ilam
    City - Persian: ایلام
    Province: Ilam
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6967114459
    Phone: +98 84 3222 7134
    Mobile: +98 912 500 7698
    Fax:
    Email: shirin.marzoughi@gmail.com
    Web page address:

Protocol summary

Study aim
Comparative study of the clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and cold ceramic in treating the pulp of mandibular second molars with reversible pulpitis.
Design
Parallel-group, double-blind, randomized, phase 2-3 clinical trial on 50 patients. A table of random numbers was used for randomization.
Settings and conduct
In children who refer to the pediatric dental clinic for treatment of pulp in mandibular second molar teeth with reversible pulpitis, after initial radiography, pulpotomy treatment is performed with a standard protocol. Pulp chamber seal is done for each patient using Mineral Trioxide Aggregate (MTA) or cold ceramic. then if there are no signs and symptoms of treatment failure, the final restoration is done with Stainless Steel Crown (SSC). Clinical evaluation of treatment results of 3, 6 and 12 months and radiographic evaluations are performed in 6 and 12 month periods. The patient and the evaluator of the treatment results will not know what substance was used to flood the canal in each patient
Participants/Inclusion and exclusion criteria
Patients who do not have any systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex, do not need general anesthesia and sedation, have good individual and family cooperation. deep caries with pulp exposure during caries removal.
Intervention groups
Intervention A: The remaining pulp is covered with paste MTA (cerkamed medical company poland ). Intervention B: The remaining pulp is covered with cold ceramic paste (Sarv Javaid modares, Iran).
Main outcome variables
The percentage of occurrence of pain; sensitivity to accuracy; swelling; pathological laziness; root lucency; internal or external root analysis; Widening of the Periodontal Ligament (PDL); bone loss; and lamina dura integrity

General information

Reason for update
According to endodontic and pediatric professors, reversible pupitis is correct term.
Acronym
IRCT registration information
IRCT registration number: IRCT20230719058851N1
Registration date: 2023-07-27, 1402/05/05
Registration timing: prospective

Last update: 2023-12-20, 1402/09/29
Update count: 3
Registration date
2023-07-27, 1402/05/05
Registrant information
Name
Faeze Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3572 2730
Email address
faezeazizi96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molar with reversible pulpitis in 3-6 years old children: a randomized clinical trial
Public title
Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molar with reversible pulpitis in 3-6 years old children: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of two-thirds of the root length in terms of radiography; and lack of radiographic evidence of pulp degeneration, such as internal or external root resorption, furca radiolucency, intraradicular or periapical bone destruction, pulp stones. Includes patients who have no systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex. They have good individual and family cooperation, deep pitted lesions whose pulp is exposed during caries removal.
Exclusion criteria:
The presence of any clinical and radiographic symptoms indicating pulpal degeneration or physiological analysis of more than 2/3 of the root (imminence of tooth loss) non-physiological analysis of the root or possibility of proper tooth restoration.
Age
From 3 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple method using a table of random numbers will be used to randomly select people; In this way, first, the order "AB" is considered for the odd number, and the order "BA" is considered for the even number. Then we refer to the table, choose a column randomly and if the first selected number is odd, we use the order 'AB'; In this way, the first person in group A will receive Mineral Trioxide Aggregate treatment and the next person will receive cold ceramic treatment spontaneously in group B. In the same way, if the number obtained is even, consider the order of BA and the first person will be placed in group B and receive cold ceramic treatment, and the next person will automatically be placed in group A and receive Mineral Trioxide Aggregate treatment. This work is repeated for 25 times to get 25 samples in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical and radiographic evaluations are performed by a person who does not know the type of substance used in each group. - The patient will not know the type of material used in each tooth.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islam university of medical science
Street address
Pajoohesh blvd
City
Ilam
Province
Ilam
Postal code
6967114459
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.MEDILAM.REC.1402.111

Health conditions studied

1

Description of health condition studied
Mandibular molars reversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Frequency of pain in treated molars
Timepoint
3,6 and 12 months after treatment
Method of measurement
The history of the presence or absence of spontaneous pain after the treatment is asked from the patient. (Yes/No)

2

Description
The frequency of occurrence of sensitivity to dex in treated primary molars
Timepoint
3,6 and 12 months after treatment
Method of measurement
During a clinical examination with a precision test, the patient is asked if there is any sensitivity or not

3

Description
The frequency of occurrence swelling in treated primary molars
Timepoint
3,6 and 12 months after treatment
Method of measurement
A clinical examination is performed to detect the presence or absence of swelling

4

Description
The frequency of occurrence fistula in treated primary molars
Timepoint
3,6 and 12 months after treatment
Method of measurement
A clinical examination is performed to detect the presence or absence of fistula.

5

Description
The frequency of occurrence pathologic mobility in treated primary molars
Timepoint
3,6 and 12 months after treatment
Method of measurement
A clinical examination is performed to detect the presence or absence of pathologic mobility.

6

Description
The frequency of occurrence of root lucency in radiographic images in treated primary molars
Timepoint
6 and 12 month after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of lucency around the root

7

Description
The frequency of occurrence of internal resorbtion in radiographic images in treated primary molars
Timepoint
6 and 12 month after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of internal resorbtion

8

Description
The frequency of occurrence of external resorbtion in radiographic images in treated primary molars
Timepoint
6 and 12 month after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of external resorbtion

9

Description
The frequency of occurrence of PDL widening in radiographic images in treated primary molars
Timepoint
6 and 12 month after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of PDL widening

10

Description
The frequency of occurrence of bone resorbtion in radiographic images in treated primary molars
Timepoint
6 and 12 month after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of bone resorbtion

11

Description
The frequency of occurrence of lamina dura disintegration in radiographic images in treated primary molars
Timepoint
6 and 12 month after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of lamina dura disintegration

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with two millimeters of paste (cerkamed Medical Company Poland) MTA+. which will be obtained by mixing the powder with sterile saline at a ratio of 3:1 and is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth.
Category
Treatment - Other

2

Description
Intervention group B : Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with three millimeters of paste cold ceramic is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric dental clinic
Full name of responsible person
shirin marzughi
Street address
seyedshohada blvd
City
ilam
Province
Ilam
Postal code
6967114459
Phone
+98 912 500 7698
Email
shirin.marzoughi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Maryam kazempour
Street address
pajoohesh blvd
City
Ilam
Province
Ilam
Postal code
6931851147
Phone
+98 84 3333 4060
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shirin Marzughi
Position
Assistante professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pajoohesh blvd
City
ilam
Province
Ilam
Postal code
6967114459
Phone
+98 84 3222 7134
Email
shirin.marzoughi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shirin Marzughi
Position
Assistant profesor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pajoohesh blvd
City
ilam
Province
Ilam
Postal code
6967114459
Phone
+98 84 3222 7134
Email
shirin.marzoughi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Faeze azizi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Daneshjoo blvd
City
ilam
Province
Ilam
Postal code
6967114459
Phone
+98 84 2572 2730
Email
faezeazizi96@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shareable
When the data will become available and for how long
Access period 6 months after publication of results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
No other conditions are required
From where data/document is obtainable
Contact via mail : faezeazizi96@gmail.com
What processes are involved for a request to access data/document
As soon as the request is received, the documents will be provided to the requester within a week
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