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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Other: MTA based pulpotomy; Other: Collagen based pulpotomy

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: Interventional
• Enrollment (Anticipated): 19
• 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: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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: 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.; Tooth will be restored with stainless steel crown.	Other: 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.; 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.
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: 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.; Tooth will then be restored with stainless steel crown.	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	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	binary outcome detected with periapical x-ray by parallel technique using XCP film holder	up to 24 week
absence of swelling	binary outcome detected with periapical x-ray by parallel technique using XCP film holder	up to 24 week

Collaborators and Investigators

• Sponsor: sherouk atef elsayed
• Collaborators: Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: April 23, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 251293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No