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

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

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.

Study Overview

• Status: Completed
• Conditions: Caries, Dental
• Intervention / Treatment: Procedure: Partial Pulpotomy; Drug: Pulp Capping Agents

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06510
    • Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Deep dentine caries with pulp exposure

Exclusion Criteria:

• Pulp exposure without hemorrhage control

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biodentine; Partial pulpotomy treatment with Biodentine	Procedure: Partial Pulpotomy; Partial removal of inflamed pulp tissue in cariously exposed teeth; Other Names: Cvek Pulpotomy, Miniature Pulpotomy; Drug: Pulp Capping Agents; Biocompatible materials; Other Names: Pulp Capping Materials
Active Comparator: Calcium Hydroxide; Partial pulpotomy treatment with Calcium Hydroxide	Procedure: Partial Pulpotomy; Partial removal of inflamed pulp tissue in cariously exposed teeth; Other Names: Cvek Pulpotomy, Miniature Pulpotomy; Drug: Pulp Capping Agents; Biocompatible materials; Other Names: Pulp Capping Materials
Experimental: Mineral Trioxide Aggregate; Partial pulpotomy treatment with Mineral Trioxide Aggregate	Procedure: Partial Pulpotomy; Partial removal of inflamed pulp tissue in cariously exposed teeth; Other Names: Cvek Pulpotomy, Miniature Pulpotomy; Drug: Pulp Capping Agents; Biocompatible materials; Other Names: Pulp Capping Materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Root development	Root length measurement in pixels with Image J Software Program	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Didem Sakaryali
• Investigators: Study Chair: Alev Alacam, DDS, PhD, Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2013
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): October 17, 2017

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: MTA; Biodentine; Partial pulpotomy; Cariously exposed pulp; Image J Software
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 1047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No