Evaluation of clinical and radiographic success and failure of Mineral trioxide aggregate (MTA) and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis in 3-6 years old children: a randomized clinical trial
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Protocol summary
Comparative evaluation of of MTA and Biodentine in pulp therapy of mandibular primary molar with irreversible pulpitis
Comparative evaluation of of MTA and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis
Comparative evaluation of of MTA and Biodentine in pulp therapy of mandibular primary molar with irreversiblereversible pulpitis
بررسی مقایسه ای (Mineral trioxide aggregate) MTA و Biodentine در درمان پالپ مولر های شیری فک پایین با پالپیت نابرگشت پذیر
بررسی مقایسه ای سنگدانه های تری اکسید معدنی( MTA ) و بایودنتین در درمان پالپ مولر های شیری فک پایین با پالپیت برگشت پذیر
بررسی مقایسه ای سنگدانه های تری اکسید معدنی(Mineral trioxide aggregate) MTA ) و Biodentineبایودنتین در درمان پالپ مولر های شیری فک پایین با پالپیت نابرگشتبرگشت پذیر
General information
Typographical mistakes
"Irreversible pulpitis" is correct.
According to endodontic and pediatric professors, reversible pulpitis is the correct term.
Typographical mistakes "IrreversibleAccording to endodontic and pediatric professors, reversible pulpitis" is the correct term.
اشتباه تایپی
"پالپیت برگشت ناپذیر" صحیح است.
طبق نظر اساتید اندو و کودکان، پالپیت برگشت پذیر درست است.
اشتباه تایپی "طبق نظر اساتید اندو و کودکان، پالپیت برگشت ناپذیر" صحیحپذیر درست است.
Evaluation of clinical and radiographic success and failure of MTA and Biodentine in pulp therapy of mandibular primary molar with irreversible pulpitis
Evaluation of clinical and radiographic success and failure of MTA and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis
Evaluation of clinical and radiographic success and failure of MTA and Biodentine in pulp therapy of mandibular primary molar with irreversiblereversible pulpitis
بررسی موفقیت و شکست بالینی و رادیوگرافیک MTA و بیودنتین در درمان پالپ مولر های شیری فک پایین با پالپیت برگشت ناپذیر
بررسی موفقیت و شکست بالینی و رادیوگرافیک MTA و بیودنتین در درمان پالپ مولر های شیری فک پایین با پالپیت برگشت پذیر
بررسی موفقیت و شکست بالینی و رادیوگرافیک MTA و بیودنتین در درمان پالپ مولر های شیری فک پایین با پالپیت برگشت ناپذیرپذیر
Evaluation of clinical and radiographic success and failure of MTA and Biodentine 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 Biodentine in pulp therapy of mandibular primary molar with reversible 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 Biodentine in pulp therapy of mandibular primary molar with irreversiblereversible pulpitis in 3-6 years old children: a randomized clinical trial
بررسی درصد فراوانی موفقیت و شکست بالینی و رادیوگرافیک MTA و Biodentine در درمان پالپ مولر های شیری فک پایین با پالپیت برگشت ناپذیر در کودکان 3-6 سال : یک مطالعه کارآزمایی بالینی
بررسی درصد فراوانی موفقیت و شکست بالینی و رادیوگرافیک سنگدانه های تری اکسید معدنی (MTA) و بایودنتین در درمان پالپ مولر های شیری فک پایین با پالپیت برگشت پذیر در کودکان 3-6 سال : یک مطالعه کارآزمایی بالینی
بررسی درصد فراوانی موفقیت و شکست بالینی و رادیوگرافیک سنگدانه های تری اکسید معدنی (MTA) و Biodentineبایودنتین در درمان پالپ مولر های شیری فک پایین با پالپیت برگشت ناپذیرپذیر در کودکان 3-6 سال : یک مطالعه کارآزمایی بالینی
Protocol summary
Study aim
Comparative evaluation of of MTA and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis
Design
A parallel-group, double-blind, randomized, phase 2-3 clinical trial on 58 patients. A table of random numbers was used for randomization.
Settings and conduct
In children refer to the specialized children's office in Ilam city for pulp therapy in mandibular primary molar teeth with reversible pulpitis, after preparing the initial radiograph and pulpotomy, the remaining pulp is covered for each patient with using Mineral Trioxide Aggregate (MTA) or Biodentine. After one week, if there are no signs and symptoms of treatment failure, the final restoration is done with Stainless Steel Crown. Clinical evaluation of treatment results at 3, 6, 9, and 12 months and radiographic evaluations are performed at 6- and 12-month periods. The patient and the evaluator of the treatment results will not know what substance was used.
Participants/Inclusion and exclusion criteria
- Inclusion criteria: patients without any systemic diseases, allergic reactions, do not need general anesthesia and sedation, good cooperation, Deep cavity lesions with vital pulp exposure, no history of spontaneous or nocturnal pain; Absence of clinical signs such as swelling; The presence of two-thirds of the root length radiographically; and lack of radiographic evidence of pulp degeneration
-Exclusion criteria: lack of parental consent to participate in the study, teeth that could not be SSC.
Intervention groups
Intervention A: The remaining pulp is covered with paste MTA.
Intervention B: The remaining pulp is covered with paste Biodentine.
Main outcome variables
the percentage of occurrence of pain; sensitivity to precussion; swelling; fistula; pathological mobility; root lucency; internal or external root resorption; Widening of the Periodontal Ligament; bone loss; and lack of lamina dura integrity
General information
Reason for update
According to endodontic and pediatric professors, reversible pulpitis is the correct term.
Acronym
IRCT registration information
IRCT registration number:IRCT20230718058836N1
Registration date:2023-07-22, 1402/04/31
Registration timing:prospective
Last update:2024-05-14, 1403/02/25
Update count:2
Registration date
2023-07-22, 1402/04/31
Registrant information
Name
Pardis Sahraeian Jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 7363
Email address
pardis.sahraj@hotmail.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 Biodentine 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 MTA and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Initial inclusion criteria include 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 cavity lesions whose pulp is exposed during caries removal and are vital, no history of spontaneous or nocturnal pain; Absence of clinical signs such as swelling, fistula, sensitivity to precussion or palpation, pathological mobility; teeth in which hemostasis is achieved within 5 minutes during the clinical procedure; The presence of two-thirds of the root length radiographically; and lack of radiographic evidence of pulp degeneration, such as internal or external root resorption, furca radiolucency, intraradicular or periapical bone destruction, pulp stones.
Exclusion criteria:
Age
From 3 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple method using random number tables will be used to 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 MTA treatment and the next person will receive Biodentine treatment spontaneously in group B. In the same way, if the obtained number is even, the "BA" order is taken into consideration and the first person is placed in group B and receives Biodentine treatment, and the next person is automatically placed in group A and receives MTA treatment. This work is repeated for 29 times to obtain 29 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 consumed 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 Shiraz University of Medical Sciences
Street address
Ilam Faculty of Dentistry, Pazhouhesh Blvd.
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.MEDILAM.REC.1402.110
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis of mandibular primary molar
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
The frequency of pain in sealed primary molars
Timepoint
Three, six, nine and 12 months after treatment
Method of measurement
The patient is asked about the presence or absence of spontaneous pain after treatment (yes/no).
2
Description
The percentage of frequency of occurrence of tooth sensitivity to pecussion in sealed primary molars
Timepoint
Three, six, nine and 12 months after treatment
Method of measurement
During a clinical examination with a precussion test, the patient is asked if there is any sensitivity or not
3
Description
The frequency of swelling in sealed primary molars
Timepoint
Three, six, nine and 12 months after treatment
Method of measurement
A clinical examination is performed to detect the presence or absence of swelling.
4
Description
The percentage of frequency of occurrence of fistula in sealed primary molars
Timepoint
Three, six, nine and 12 months after treatment
Method of measurement
A clinical examination is performed to detect the presence or absence of fistula.
5
Description
Frequency of occurrence of pathological mobility in sealed primary molars
Timepoint
Three, six, nine and 12 months after treatment
Method of measurement
A clinical examination is performed to detect the presence or absence of pathological mobility.
6
Description
The frequency of occurrence of root lucency in radiographic images in sealed primary molars
Timepoint
Six and 12 months after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of lucency around the root
7
Description
Frequency of internal resortion in radiographic images of sealed primary molars
Timepoint
Six and 12 months after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of internal root resorption.
8
Description
The percentage of occurrence of root external resorption in radiographic images of sealed primary molars
Timepoint
Six and 12 months after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of external resorption of the root
9
Description
The frequency of occurrence of PDL widening in the radiographic images of sealed primary molars
Timepoint
Six and 12 months after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of PDL widening.
10
Description
Frequency percentage of bone loss in radiographic images of sealed primary molars
Timepoint
Six and 12 months after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of bone loss.
11
Description
Frequency of lamina dura non-integrity in radiographic images of sealed primary molars
Timepoint
Six and 12 months after treatment
Method of measurement
Radiographic examination is performed to detect the presence or absence of lamina dura integrity
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 first local anesthesia with lidocaine 2% and epinephrine (Daropakhsh/Iran) 1:80000 is performed. The decayed crown is removed under sterile conditions using a rubberdam and a No. 4 round slow-speed bur, and in the next step, the roof of the pulp chamber is removed with a 330 high-speed bur along with water, and access to the crown will be completed. Using process bur No. 6, the crown pulp is completely removed from the entrance of the canal and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the coronal pulp excision site at the entrance of the canals using sterile cotton moistened with normal saline for 5 minutes. If hemostasis does not occur, the tooth is excluded from the study. In group A, the remaining pulp is covered with 2 mm of MTA paste (at a ratio of 3 to 1). 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 symptoms, pain, sensitivity to precussion, swelling, mobility 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: 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 first local anesthesia with lidocaine 2% and epinephrine (Daropakhsh/Iran) 1:80000 is performed. The decayed crown is removed under sterile conditions using a rubberdam and a No. 4 round slow-speed bur, and in the next step, the roof of the pulp chamber is removed with a 330 high-speed bur along with water, and access to the crown will be completed. Using process bur No. 6, the crown pulp is completely removed from the entrance of the canal and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the coronal pulp excision site at the entrance of the canals using sterile cotton moistened with normal saline for 5 minutes. If hemostasis does not occur, the tooth is excluded from the study. In group B, the remaining pulp is covered with 2 mm of Biodentine paste. 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 symptoms, pain, sensitivity to precussion, swelling, mobility 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
Specialized pediatric office
Full name of responsible person
Dr.Shirin Marzoughi
Street address
Unit 19, 4th Floor, Noor Doctors Building, Kaj Ave., Seyyed Al Shahada Blvd.
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 939 096 6000
Email
shirin.marzoughi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Shirin Marzoughi
Street address
Department of Pediatric Dentistry, Ilam Faculty of Dentistry
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5705
Email
shirin.marzoughi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?