search
Back to results

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

Primary Purpose

Dental Caries in Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MTA based pulpotomy
Collagen based pulpotomy
Sponsored by
sherouk atef elsayed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Primary molar tooth not more than one-third of root resorption. Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically. systemically healthy. cooperative patients who will comply to follow up visits. Exclusion Criteria: Children with medical, physical, or mental conditions. Primary molars with any congenital deformities. Previously accessed teeth. At operative procedure haemorrhage control is unachievable after pulpotomy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Collagen based pulpotomy

    MTA based pulpotomy

    Arm 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: 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Absence of internal root resorption
    binary outcome detected with periapical x-ray by parallel technique using XCP film holder
    absence of swelling
    binary outcome detected with periapical x-ray by parallel technique using XCP film holder

    Full Information

    First Posted
    December 21, 2022
    Last Updated
    April 23, 2023
    Sponsor
    sherouk atef elsayed
    Collaborators
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05829304
    Brief Title
    A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars
    Official Title
    A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    sherouk atef elsayed
    Collaborators
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries in Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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).
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    19 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Collagen based pulpotomy
    Arm Type
    Active Comparator
    Arm 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: 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.
    Arm Title
    MTA based pulpotomy
    Arm Type
    Active Comparator
    Arm 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: 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.
    Intervention Type
    Other
    Intervention Name(s)
    MTA based pulpotomy
    Intervention Description
    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
    Intervention Name(s)
    Collagen based pulpotomy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    postoperative pain
    Description
    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.
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    Absence of internal root resorption
    Description
    binary outcome detected with periapical x-ray by parallel technique using XCP film holder
    Time Frame
    up to 24 week
    Title
    absence of swelling
    Description
    binary outcome detected with periapical x-ray by parallel technique using XCP film holder
    Time Frame
    up to 24 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Primary molar tooth not more than one-third of root resorption. Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically. systemically healthy. cooperative patients who will comply to follow up visits. Exclusion Criteria: Children with medical, physical, or mental conditions. Primary molars with any congenital deformities. Previously accessed teeth. At operative procedure haemorrhage control is unachievable after pulpotomy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sherouk Elsayed, bachelor
    Phone
    +201005544373
    Email
    sherouk.elsayed@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    passant nagi, lecturer
    Phone
    +201280557107
    Email
    passant.nagi@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34393127
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs