A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars

Study Overview
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Brief Summary
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To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital primary molars.

Detailed Description
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Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration using mineral trioxide aggregate of the remaining pulp tissue have been utilized to date. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promote the healing of the root pulp and be compatible with the physiological process of root resorption. Collagen, which is available for dental implication, is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contaminations. The collagen particles can be sterilized by various methods like irradiation, dry heat, and ethylene oxide, among which irradiation is the most frequently used method as it does not affect the structural stability

Official Title
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A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Other: MTA based pulpotomy
* Other: Collagen based pulpotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary molar tooth not more than one-third of root resorption. Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically. systemically healthy. cooperative patients who will comply to follow up visits. Exclusion Criteria: Children with medical, physical, or mental conditions. Primary molars with any congenital deformities. Previously accessed teeth. At operative procedure haemorrhage control is unachievable after pulpotomy.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collagen based pulpotomy<br>Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group I collagen-based Pulpotomy: After complete haemostasis, collagen based pulpotomy will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm then the rest of the pulp chamber will be filled with glass ionomer cement. Tooth will be restored with stainless steel crown. | Other: MTA based pulpotomy<br>* The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient.<br>Other: Collagen based pulpotomy<br>* The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient.<br>|
| Active Comparator: MTA based pulpotomy<br>Application of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group II MTA pulpotomy: After complete hemostasis, MTA+ Cerkamed will be manipulated to obtain a putty mix. This mix will be placed over the radicular pulp. condensation of the mix with a moistened cotton pellet, followed by application of glass ionomer cement. Tooth will then be restored with stainless steel crown. | Other: MTA based pulpotomy<br>* The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient.<br>Other: Collagen based pulpotomy<br>* The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | postoperative pain following the placement of restoration by questioning the patient. using numerical pain rating scale Zero means patient have no pain, while 10 represents the most intense pain possible. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of internal root resorption | binary outcome detected with periapical x-ray by parallel technique using XCP film holder | up to 24 week | 
| absence of swelling | binary outcome detected with periapical x-ray by parallel technique using XCP film holder | up to 24 week |