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Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars

NCT03838094 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-12

No results posted yet for this study

Summary

Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) of cariously exposed vital immature mandibular first permanent molars.

Materials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analysed.

Conditions

  • Carious Exposure of Pulp

Interventions

BIOLOGICAL

Biodentine

it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.

BIOLOGICAL

MTA

MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Gihan M Abuelniel ,PhD

    lead OTHER

Principal Investigators

  • Gihan M Abuelniel, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-08-31
Completion
2018-09-30

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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 NCT03838094 on ClinicalTrials.gov