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

Sponsor
sherouk atef elsayed (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05829304
Collaborator
Cairo University (Other)
19
2
13

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: MTA based pulpotomy
  • Other: Collagen based pulpotomy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
the blinding is not possible (unfortunately) due to the nature of the trial. Trial participants, outcome assessors and statistician will be blinded.
Primary Purpose:
Treatment
Official Title:
A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Absence of internal root resorption [up to 24 week]

    binary outcome detected with periapical x-ray by parallel technique using XCP film holder

  2. absence of swelling [up to 24 week]

    binary outcome detected with periapical x-ray by parallel technique using XCP film holder

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • sherouk atef elsayed
  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
sherouk atef elsayed, A comparative Clinical and Radiographic Study Of Collagen based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars, Cairo University
ClinicalTrials.gov Identifier:
NCT05829304
Other Study ID Numbers:
  • 251293
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2023