A Comparative Clinical and Radiographic Study of Collagen Based Pulpotomy Versus Biodentine Pulpotomy in Children With Cariously Exposed Vital Primary Molars

NCT05479877 | Unknown Early Phase 1 DMC

• 1 other identifier: 19071991
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 of the remaining pulp tissue using mineral trioxide aggregate and recently Biodentine have been utilized. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promoting the healing of the root pulp and be compatible with the physiological process of root resorption. Searching for more pulpotomy agents, Collagen, a protein that's present abundantly in humans, is an important component of connective tissues and performs multiple functions including wound healing. Enamel and dentin contain Collagen as one of the components in their organic ground matrix. Collagen has been used widely in dentistry in periodontal and implant therapy as scaffold for preventing the migration of epithelial cells and encouraging wound repopulation by cells with high regenerative potential. The Collagen available for dental implication is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contamination. The collagen particles

Conditions

Carious Exposure of Pulp

Keywords

pulpotomy; biodentine; collagen

Outcome Measures

Primary Outcomes (1)

• absence of internal root resorption

  radiographic measurement of internal root resorption

  12 months

Secondary Outcomes (1)

• absence of pain and swelling

  12 months

Study Arms (2)

(Experimental group) collagen based Pulpotomy

EXPERIMENTAL

(sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India)

Drug: sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India

(Control group) Biodentine pulpotomy

ACTIVE COMPARATOR

Biodentine (Septodont, Saint-Maur-des-Fossés, France)

Drug: Biodentine (Septodont, Saint-Maur-des-Fossés, France)

Interventions

sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India DRUG

Collagen based pulpotomy will be applied (sterile medicated collagen particles, Biofil-AB ,Eucare Pharmaceuticals Pvt. Ltd, Chennai, India)according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm

(Experimental group) collagen based Pulpotomy

Biodentine (Septodont, Saint-Maur-des-Fossés, France) DRUG

Biodentine (Septodont, Saint-Maur-des-Fossés, France) will be applied according to the manufacturer's instructions and placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet.

(Control group) Biodentine pulpotomy

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children:
• Aged 4 to 7, in good general health and medically free.
• Cooperative patients who will comply to follow ups.
• Parents provided with written informed consent. • Teeth:
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• Bilaterally Carious vital primary molars with reversible pulpitis.
• Restorable teeth with no more than 1/3 of root resorption.

You may not qualify if:

• Children:
• Children with medical, physical, or mental conditions.
• Unable to attend follow up visits. • Teeth:
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• Primary molars with any congenital anomalies.
• Previously accessed teeth.
• At operative procedure, haemorrhage control is unachievable after pulpotomy.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

tricalcium silicate; Septodont

Central Study Contacts

Nihal Bayoumi, Msc

CONTACT

+201227610630; nihal.mostafa@dentistry.cu.edu.eg

Passant Nagi, Lecturer

CONTACT

+201120655633; passant.nagi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share