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Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

NCT03838068 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-12-27

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) preserving the vitality of traumatized immature anterior permanent teeth.

Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Included teeth were randomly assigned to either a control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth 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 analyzed.

Conditions

  • Pulp Exposure, Dental

Interventions

BIOLOGICAL

Biodentine

Biodentine is considered a calcium silicate cement

BIOLOGICAL

mineral trioxide aggregate

calcium based silicate cement

PROCEDURE

cervical pulpotomy

coronal pulp tissue was removed till the orifice

DRUG

Local Anesthetics Procaine

40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Gihan M Abuelniel ,PhD

    lead OTHER

Principal Investigators

  • Gihan M Abuelniel · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-18
Primary Completion
2018-12-30
Completion
2019-08-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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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 NCT03838068 on ClinicalTrials.gov