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

sherouk atef elsayed

Status: Not yet enrolling

Conditions: Dental Caries in Children

Treatments: Other: MTA based pulpotomy; Other: Collagen based pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05829304

251293

Details and patient eligibility

About

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

Full 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

Enrollment: 19 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Collagen based pulpotomy

Active Comparator group

Description:

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: 1. 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. 2. Tooth will be restored with stainless steel crown.

Treatment:

Other: MTA based pulpotomy

Other: Collagen based pulpotomy

MTA based pulpotomy

Active Comparator group

Description:

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: 1. 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. 2. Tooth will then be restored with stainless steel crown.

Treatment:

Other: MTA based pulpotomy

Other: Collagen based pulpotomy