A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars
A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sherouk Elsayed, bachelor
- Phone Number: +201005544373
- Email: sherouk.elsayed@dentistry.cu.edu.eg
Study Contact Backup
- Name: passant nagi, lecturer
- Phone Number: +201280557107
- Email: passant.nagi@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Collagen based pulpotomy
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:
|
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.
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.
|
|
Active Comparator: MTA based pulpotomy
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:
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain
Time Frame: 3 days
|
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
Time Frame: up to 24 week
|
binary outcome detected with periapical x-ray by parallel technique using XCP film holder
|
up to 24 week
|
|
absence of swelling
Time Frame: up to 24 week
|
binary outcome detected with periapical x-ray by parallel technique using XCP film holder
|
up to 24 week
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 251293
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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