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

Study Overview
=================
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.

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

Conditions
-----------------
Caries, Dental

Intervention / Treatment
-----------------
* Procedure: Partial Pulpotomy
* Drug: Pulp Capping Agents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deep dentine caries with pulp exposure Exclusion Criteria: Pulp exposure without hemorrhage control

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biodentine, Cariously exposed pulp, MTA, Partial pulpotomy, Image J Software