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OpenTrials
Completed

NCT Number: NCT03426046

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

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.

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Key information

Conditions

Caries, Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry

Ankara, 06510, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Deep dentine caries with pulp exposure

Exclusion criteria

  • Pulp exposure without hemorrhage control

Treatment and study plan

Partial pulpotomy

Procedure

Partial removal of inflamed pulp tissue in cariously exposed teeth

Other names: Cvek Pulpotomy, Miniature Pulpotomy

Pulp Capping Agents

Drug

Biocompatible materials

Other names: Pulp Capping Materials

Primary outcomes

  1. Root development

    Time frame: 12 months

    Root length measurement in pixels with Image J Software Program

Secondary outcomes

  1. Clinical Evaluation

    Time frame: 12 months

    Percussion sensitivity evaluation with blunt end of a dental instrument comparing with contralateral or next healthy tooth

  2. Radiographical Evaluation

    Time frame: 12 months

    Integrity of lamina dura with visual evaluation of radiopaque line around the root using image plate system

Sponsors and collaborators

Lead sponsor

Didem Sakaryali

Other

Registry information

Official study title

Partial Pulpotomy Treatment Of Immature Permanent Molars: A Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Feb 8, 2018
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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