Treatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy

NCT ID: NCT03426046

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-22

Study Completion Date

2017-10-17

Brief Summary

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The aim of this randomized controlled trial is to compare partial pulpotomy treatments with Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate root developments with Image J Software Program. The null hypothesis of this study is Biodentine® will promote healing with high success rates and induce root development more than CH and MTA.

Detailed Description

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The purpose of this study was to evaluate clinical and radiographical success of three different materials in partial pulpotomy treatment. 50 patients with 54 asymptomatic, cariously exposed young permanent mandibular molar teeth were included to the study. The teeth were randomly divided into three main groups which were; calcium hydroxide, MTA and Biodentine® and finally restorated with stainless steel crowns. Pain, percussion sensitivity, palpation sensitivity of soft tissue around the tooth, root development, presence of lesion, integrity of lamina dura were evaluated clinically and radiographically during 12 months and recorded for each. Also, Image J Program with Turbo-Reg plug in was used for standardization of the radiographs and to determine the increase in root length.

Conditions

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Caries, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biodentine

Partial pulpotomy treatment with Biodentine

Group Type EXPERIMENTAL

Partial Pulpotomy

Intervention Type PROCEDURE

Partial removal of inflamed pulp tissue in cariously exposed teeth

Pulp Capping Agents

Intervention Type DRUG

Biocompatible materials

Calcium Hydroxide

Partial pulpotomy treatment with Calcium Hydroxide

Group Type ACTIVE_COMPARATOR

Partial Pulpotomy

Intervention Type PROCEDURE

Partial removal of inflamed pulp tissue in cariously exposed teeth

Pulp Capping Agents

Intervention Type DRUG

Biocompatible materials

Mineral Trioxide Aggregate

Partial pulpotomy treatment with Mineral Trioxide Aggregate

Group Type EXPERIMENTAL

Partial Pulpotomy

Intervention Type PROCEDURE

Partial removal of inflamed pulp tissue in cariously exposed teeth

Pulp Capping Agents

Intervention Type DRUG

Biocompatible materials

Interventions

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Partial Pulpotomy

Partial removal of inflamed pulp tissue in cariously exposed teeth

Intervention Type PROCEDURE

Pulp Capping Agents

Biocompatible materials

Intervention Type DRUG

Other Intervention Names

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Cvek Pulpotomy, Miniature Pulpotomy Pulp Capping Materials

Eligibility Criteria

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Inclusion Criteria

* Deep dentine caries with pulp exposure

Exclusion Criteria

* Pulp exposure without hemorrhage control
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Didem Sakaryali

OTHER

Sponsor Role lead

Responsible Party

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Didem Sakaryali

DDS, PhD, Dr, Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alev Alacam, DDS, PhD

Role: STUDY_CHAIR

Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry

Locations

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Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1047

Identifier Type: -

Identifier Source: org_study_id

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