Partial Pulpotomy Treatment Of Immature Permanent Molars: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Root development
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Deep dentine caries with pulp exposure
Exclusion Criteria
- •Pulp exposure without hemorrhage control
Arms & Interventions
Mineral Trioxide Aggregate
Partial pulpotomy treatment with Mineral Trioxide Aggregate
Intervention: Pulp Capping Agents (Drug)
Biodentine
Partial pulpotomy treatment with Biodentine
Intervention: Partial Pulpotomy (Procedure)
Biodentine
Partial pulpotomy treatment with Biodentine
Intervention: Pulp Capping Agents (Drug)
Calcium Hydroxide
Partial pulpotomy treatment with Calcium Hydroxide
Intervention: Partial Pulpotomy (Procedure)
Calcium Hydroxide
Partial pulpotomy treatment with Calcium Hydroxide
Intervention: Pulp Capping Agents (Drug)
Mineral Trioxide Aggregate
Partial pulpotomy treatment with Mineral Trioxide Aggregate
Intervention: Partial Pulpotomy (Procedure)
Outcomes
Primary Outcomes
Root development
Time Frame: 12 months
Root length measurement in pixels with Image J Software Program
Secondary Outcomes
- Clinical Evaluation(12 months)
- Radiographical Evaluation(12 months)
Investigators
Didem Sakaryali
DDS, PhD, Dr, Principal investigator
Gazi University