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

Phase 4

Completed

• Conditions: Caries, Dental
• Interventions: Procedure: Partial Pulpotomy; Drug: Pulp Capping Agents

• Registration Number: NCT03426046
• Lead Sponsor: Didem Sakaryali

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-11-22
• Primary Completion: 2016-04-30
• Study Completion: 2017-10-17
• Study First Submitted: 2018-01-25
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-08
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Deep dentine caries with pulp exposure

Exclusion Criteria

• Pulp exposure without hemorrhage control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biodentine	Partial Pulpotomy	Partial pulpotomy treatment with Biodentine
Biodentine	Pulp Capping Agents	Partial pulpotomy treatment with Biodentine
Calcium Hydroxide	Partial Pulpotomy	Partial pulpotomy treatment with Calcium Hydroxide
Mineral Trioxide Aggregate	Pulp Capping Agents	Partial pulpotomy treatment with Mineral Trioxide Aggregate
Calcium Hydroxide	Pulp Capping Agents	Partial pulpotomy treatment with Calcium Hydroxide
Mineral Trioxide Aggregate	Partial Pulpotomy	Partial pulpotomy treatment with Mineral Trioxide Aggregate

Primary Outcome Measures

Name	Time	Method
Root development	12 months	Root length measurement in pixels with Image J Software Program

Secondary Outcome Measures

Name	Time	Method
Radiographical Evaluation	12 months	Integrity of lamina dura with visual evaluation of radiopaque line around the root using image plate system
Clinical Evaluation	12 months	Percussion sensitivity evaluation with blunt end of a dental instrument comparing with contralateral or next healthy tooth

Trial Locations

Locations (1)

Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry; 🇹🇷 Ankara, Turkey