MedTrace Logo

Bioactive Materials in Pulp Therapy of Primary Teeth

NCT04795830 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-21

No results posted yet for this study

Summary

The purpose of this study is to compare the clinical and radiographic success of a new injectable, fast setting bioceramic root repair material (BC RRM) putty with mineral trioxide aggregate (MTA) in pulpotomy procedures of primary teeth. The null hypothesis (H0) is that there is no difference in the clinical and radiographic success between the TotalFill® BC RRM™ Fast Set Putty and Produits Dentaires™ (PD™) MTA WHITE when used as a pulp dressing in pulpotomies of primary molars.

Conditions

  • Pulpitis
  • Pulp Disease, Dental

Interventions

COMBINATION_PRODUCT

Bioceramic root repair material as pulp dressing in pulpotomy in primary molars

BC RRM-F, a novel premixed bioceramic-based putty, can be used as a pulp dressing to promote pulp healing and repair with an added convenience for the pediatric patient. The aim of the present study is to evaluate the efficacy of a bioceramic root repair material as pulp dressing in pulpotomy in primary molars. The success of this material as pulpotomy dressing in primary molars will be evaluated clinically and radiographically in comparison to mineral trioxide aggregate pulpotomy. Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application. Each material's success will be evaluated by comparing its performance with or without the added peripheral seal of a stainless steel crown.

COMBINATION_PRODUCT

Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)

MTA's sealing ability, biocompatibility, ability to stimulate hard tissue formation and its regenerative ability when used in contact with pulp tissues has made MTA pulpotomy the new gold standard as opposed to formocresol pulpotomy in treating the amputated pulp stumps of primary molars.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Dina Abdelwahab, M.Sc. · Department of Pediatric Dentistry and Dental Public Health, Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-03-01
Completion
2023-05-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795830 on ClinicalTrials.gov