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

Not Applicable

Not yet recruiting

• Conditions: Dental Caries in Children

• Registration Number: NCT05829304
• Lead Sponsor: sherouk atef elsayed

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-12-21
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-23
• Last Update Submitted: 2023-04-23
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Study Start: 2023-06
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Primary molar tooth not more than one-third of root resorption.
2. Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.
3. systemically healthy.
4. cooperative patients who will comply to follow up visits.

Exclusion Criteria

1. Children with medical, physical, or mental conditions.
2. Primary molars with any congenital deformities.
3. Previously accessed teeth.
4. At operative procedure haemorrhage control is unachievable after pulpotomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative pain	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.

Secondary Outcome Measures

Name	Time	Method
absence of swelling	up to 24 week	binary outcome detected with periapical x-ray by parallel technique using XCP film holder
Absence of internal root resorption	up to 24 week	binary outcome detected with periapical x-ray by parallel technique using XCP film holder