Back to resultsTreatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy
Primary Purpose
Caries, Dental
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Partial Pulpotomy
Pulp Capping Agents
Sponsored by
About this trial
This is an interventional treatment trial for Caries, Dental focused on measuring Biodentine, Cariously exposed pulp, MTA, Partial pulpotomy, Image J Software
Eligibility Criteria
Inclusion Criteria:
- Deep dentine caries with pulp exposure
Exclusion Criteria:
- Pulp exposure without hemorrhage control
Sites / Locations
- Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Biodentine
Calcium Hydroxide
Mineral Trioxide Aggregate
Arm Description
Partial pulpotomy treatment with Biodentine
Partial pulpotomy treatment with Calcium Hydroxide
Partial pulpotomy treatment with Mineral Trioxide Aggregate
Outcomes
Primary Outcome Measures
Root development
Root length measurement in pixels with Image J Software Program
Secondary Outcome Measures
Clinical Evaluation
Percussion sensitivity evaluation with blunt end of a dental instrument comparing with contralateral or next healthy tooth
Radiographical Evaluation
Integrity of lamina dura with visual evaluation of radiopaque line around the root using image plate system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03426046
Brief Title
Treatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy
Official Title
Partial Pulpotomy Treatment Of Immature Permanent Molars: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 22, 2013 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
October 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Didem Sakaryali
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
Biodentine, Cariously exposed pulp, MTA, Partial pulpotomy, Image J Software
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodentine
Arm Type
Experimental
Arm Description
Partial pulpotomy treatment with Biodentine
Arm Title
Calcium Hydroxide
Arm Type
Active Comparator
Arm Description
Partial pulpotomy treatment with Calcium Hydroxide
Arm Title
Mineral Trioxide Aggregate
Arm Type
Experimental
Arm Description
Partial pulpotomy treatment with Mineral Trioxide Aggregate
Intervention Type
Procedure
Intervention Name(s)
Partial Pulpotomy
Other Intervention Name(s)
Cvek Pulpotomy, Miniature Pulpotomy
Intervention Description
Partial removal of inflamed pulp tissue in cariously exposed teeth
Intervention Type
Drug
Intervention Name(s)
Pulp Capping Agents
Other Intervention Name(s)
Pulp Capping Materials
Intervention Description
Biocompatible materials
Primary Outcome Measure Information:
Title
Root development
Description
Root length measurement in pixels with Image J Software Program
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical Evaluation
Description
Percussion sensitivity evaluation with blunt end of a dental instrument comparing with contralateral or next healthy tooth
Time Frame
12 months
Title
Radiographical Evaluation
Description
Integrity of lamina dura with visual evaluation of radiopaque line around the root using image plate system
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Deep dentine caries with pulp exposure
Exclusion Criteria:
Pulp exposure without hemorrhage control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alev Alacam, DDS, PhD
Organizational Affiliation
Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
Official's Role
Study Chair
Facility Information:
Facility Name
Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
City
Ankara
ZIP/Postal Code
06510
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Treatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy
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