NCT03426046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

2.4 years

First QC Date

January 25, 2018

Last Update Submit

February 9, 2018

Conditions

Caries, Dental

Keywords

BiodentineCariously exposed pulpMTAPartial pulpotomyImage J Software

Outcome Measures

Primary Outcomes (1)

  • Root development

    Root length measurement in pixels with Image J Software Program

    12 months

Secondary Outcomes (2)

  • Clinical Evaluation

    12 months

  • Radiographical Evaluation

    12 months

Study Arms (3)

Biodentine

EXPERIMENTAL

Partial pulpotomy treatment with Biodentine

Procedure: Partial PulpotomyDrug: Pulp Capping Agents

Calcium Hydroxide

ACTIVE COMPARATOR

Partial pulpotomy treatment with Calcium Hydroxide

Procedure: Partial PulpotomyDrug: Pulp Capping Agents

Mineral Trioxide Aggregate

EXPERIMENTAL

Partial pulpotomy treatment with Mineral Trioxide Aggregate

Procedure: Partial PulpotomyDrug: Pulp Capping Agents

Interventions

Partial PulpotomyPROCEDURE

Partial removal of inflamed pulp tissue in cariously exposed teeth

Also known as: Cvek Pulpotomy, Miniature Pulpotomy
BiodentineCalcium HydroxideMineral Trioxide Aggregate
Pulp Capping AgentsDRUG

Biocompatible materials

Also known as: Pulp Capping Materials
BiodentineCalcium HydroxideMineral Trioxide Aggregate

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Deep dentine caries with pulp exposure

You may not qualify if:

  • Pulp exposure without hemorrhage control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry

Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Pulp Capping and Pulpectomy Agents

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Alev Alacam, DDS, PhD

    Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
DDS, PhD, Dr, Principal investigator

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 8, 2018

Study Start

November 22, 2013

Primary Completion

April 30, 2016

Study Completion

October 17, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

TU(1)