NCT05829304

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

December 21, 2022

Last Update Submit

April 23, 2023

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Absence of internal root resorption

    up to 24 week

  • absence of swelling

    up to 24 week

Study Arms (2)

Collagen based pulpotomy

ACTIVE COMPARATOR

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.

Other: MTA based pulpotomyOther: Collagen based pulpotomy

MTA based pulpotomy

ACTIVE COMPARATOR

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.

Other: MTA based pulpotomyOther: Collagen based pulpotomy

Interventions

MTA based pulpotomyOTHER

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 pulpotomyMTA based pulpotomy
Collagen based pulpotomyOTHER

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 pulpotomyMTA based pulpotomy

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34393127BACKGROUND

Central Study Contacts

Sherouk Elsayed, bachelor

CONTACT

+201005544373sherouk.elsayed@dentistry.cu.edu.eg

passant nagi, lecturer

CONTACT

+201280557107passant.nagi@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the blinding is not possible (unfortunately) due to the nature of the trial. Trial participants, outcome assessors and statistician will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
A comparative Clinical and Radiographic Study Of Collagen based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars

Study Record Dates

First Submitted

December 21, 2022

First Posted

April 25, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

April 25, 2023

Record last verified: 2023-04