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

Caries, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426046
• Other study ID #: 1047
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2018
• Last updated: February 9, 2018
• Start date: November 22, 2013
• Est. completion date: October 17, 2017

Study information

• Verified date: February 2018
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 17, 2017
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• Deep dentine caries with pulp exposure

Exclusion Criteria:

• Pulp exposure without hemorrhage control

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

Procedure:
• Partial Pulpotomy
Partial removal of inflamed pulp tissue in cariously exposed teeth

Drug:
• Pulp Capping Agents
Biocompatible materials

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Didem Sakaryali

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root development	Root length measurement in pixels with Image J Software Program	12 months
Secondary	Clinical Evaluation	Percussion sensitivity evaluation with blunt end of a dental instrument comparing with contralateral or next healthy tooth	12 months
Secondary	Radiographical Evaluation	Integrity of lamina dura with visual evaluation of radiopaque line around the root using image plate system	12 months