To compare clinical and radiographic success rates of Metapex pulpectomy and Calcium-Enriched Mixture (CEM) Cement pulpotomy in primary molars with inflamed radicular pulp
Design
This is a randomized, blinded, multicenter (two universities and three operators) clinical trial with a parallel group design. ُThe initial sample size was calculated to be 100 teeth.
Settings and conduct
This study will be conducted in the clinics of pediatric dentistry departments of Mashhad and Yazd University of Medical Sciences. Children and their parents/caregivers will be blinded. The operators can not be blinded due to the nature of the treatments. The outcome assessors and data analyzer will also be blinded. Three pediatric dentistry residents will conduct clinical treatments. Eligible teeth will be selected and after pulp exposure following caries removal the coronal pulp will be amputated. If the pulp stumps shows the evidence of inflammation, the teeth will then be definitely included in the study and will be randomly allocated into 2 intervention groups: CEM Cement pulpotomy and Metapex pulpectomy. Following pulp therapy, the teeth will be restored with stainless steal crowns and will be followed 6, 12, 18 and 24 months postoperatively.
Participants/Inclusion and exclusion criteria
Pediatric patients aged 4-9 years
Primary molars with vital pulps and deep carious lesions
Presence of inflamed radicular pulp after pulp amputation (sever bleeding may be present that can be controlled up to 10 minutes)
Tenderness to percussion or spontaneous pain may be present
Intervention groups
CEM cement pulpotomy
Metapex Pulpectomy
Main outcome variables
Clinical and radiographic success of the treated teeth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201226049838N1
Registration date:2021-01-12, 1399/10/23
Registration timing:retrospective
Last update:2021-01-12, 1399/10/23
Update count:0
Registration date
2021-01-12, 1399/10/23
Registrant information
Name
Sedigheh Sabbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3806 7100
Email address
sabbaghsd@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-05, 1396/04/14
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of pulpectomy with CEM cement pulpotomy in primary molars; A multicenter Randomized Clinical Trial
Public title
Comparison of pulpectomy with CEM cement pulpotomy in primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pediatric patients aged 4-9 years
Primary molars with vital pulps and deep carious lesions
Presence of inflamed radicular pulp after pulp amputation (sever bleeding may be present and can be controlled up to 10 min)
Tenderness to percussion or spontaneous pain may be present
Exclusion criteria:
Evidence of Pulp necrosis
Pathologic internal or external root resorption
Pathologic mobility
Pulp canal obliteration
Age
From 4 years old to 9 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of teeth will be done by simple randomization method using a web-based randomization service (www.randomizer.org). The generated list of random numbers will be kept by those other than the operators.
Blinding (investigator's opinion)
Double blinded
Blinding description
Children and their parents/caregivers will be blinded, they will not know to which group they belong. The operators can not be blinded due to the nature of the treatments. The clinical outcome assessors will be those other than operators and they will be unaware of the treatment provided to each patient. The radiographic outcome assessors can not be blinded due to the nature of treatments. The data analyzer will just be informed about the aims of the research. He will not know which data set is belong to which group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah street, Goreishi building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.mums.sd.REC.1394.242
Health conditions studied
1
Description of health condition studied
inflamed radicular pulp of primary molars which is the indication for pulpectomy treatment
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Clinical success rate of CEM cement pulpotomy and Metapex pulpectomy
Timepoint
6, 12 months
Method of measurement
spontaneous pain, Tenderness to percussion and palpation, gingival swelling, presence of sinus tract/fistula, pathologic mobility
2
Description
Radiographic success rate of CEM cement pulpotomy and Metapex pulpectomy
Intervention group: CEM cement pulpotomy: following coronal pulp amputation, hemostasis will be attempted (up to 10 minutes), then CEM cement (BioniqueDent, Tehran, Iran) paste will be inserted to the pulp chamber to cover pulp stumps. The rest of the cavity will then be filled with light-cured resin-modified glass ionomer cement and the tooth will be restored permanently with stainless steal crown.
Category
Treatment - Other
2
Description
Intervention group: Metapex Pulpectomy: radiographic working length will be determined and radicular pulp will be extirpated. The canals will be dried with paper points. Root canals will be then filled with Metapex (Calcium Hydroxide + Iodoform) (Meta Biomed Co., Ltd, Korea). The rest of the cavity will be then filled with light-cured resin-modified glass ionomer cement and the tooth will be restored permanently with stainless steal crown.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The clinic of Pediatric dentistry department of Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sarraf Shirazi
Street address
Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
sarrafa@mums.ac.ir
2
Recruitment center
Name of recruitment center
The clinic of Pediatric dentistry department of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zahra Bahrololoumi
Street address
Imam Reza Blvd
City
Yazd
Province
Yazd
Postal code
0000000000
Phone
+98 35 3625 5881
Email
zbahrololoom@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Asgary
Street address
Daneshjoo Blvd-Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 7752
Email
saasgary@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
30
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
2
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sarraf Shirazi
Street address
School of Dentistry, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
sarrafa@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Asgary
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Iranian Center for Endodontic Research -Daneshjoo Blvd-Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 7752
Email
saasgary@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sarraf Shirazi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry-Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
sarrafa@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Sabbagh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Materials Research Center/Pediatric Dentistry Department-Dental School- Mashhad University of Medical Sciences-Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7100
Email
sedigheh.sabbagh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Will be sent on demand of individual researchers
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available