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

NCT ID: NCT05829304

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-06-30

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

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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:

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.

Group Type: ACTIVE_COMPARATOR

MTA based pulpotomy

Intervention Type: OTHER

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.

Collagen based pulpotomy

Intervention Type: OTHER

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.

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:

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.

Group Type: ACTIVE_COMPARATOR

MTA based pulpotomy

Intervention Type: OTHER

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.

Collagen based pulpotomy

Intervention Type: OTHER

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.

Interventions

MTA 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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

sherouk atef elsayed

OTHER

Sponsor Role: lead

Responsible Party

sherouk atef elsayed

A comparative Clinical and Radiographic Study Of Collagen based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Sherouk Elsayed, bachelor

Role: CONTACT

sherouk.elsayed@dentistry.cu.edu.eg

+201005544373

passant nagi, lecturer

Role: CONTACT

passant.nagi@dentistry.cu.edu.eg

+201280557107

References

Anandan V, Inbanathan J, Saket P, Krishnamoorthy V, Gandhi S, Chandrababu VK. Assessment of Clinical and Radiographic Success Rate of Formocresol-based Pulpotomy versus Collagen-based Pulpotomy: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):680-685.

Reference Type: BACKGROUND

PMID: 34393127 (View on PubMed)

Other Identifiers

251293

Identifier Type: -

Identifier Source: org_study_id