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

Sponsor
Didem Sakaryali (Other)
Overall Status
Completed
CT.gov ID
NCT03426046
Collaborator
(none)
54
Enrollment
1
Location
3
Arms
46.8
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Partial Pulpotomy
  • Drug: Pulp Capping Agents
 Phase 4

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
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Partial Pulpotomy Treatment Of Immature Permanent Molars: A Randomized Clinical Trial
Actual Study Start Date :
Nov 22, 2013
Actual Primary Completion Date :
Apr 30, 2016
Actual Study Completion Date :
Oct 17, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Root development [12 months]

      Root length measurement in pixels with Image J Software Program

    Secondary Outcome Measures

    1. Clinical Evaluation [12 months]

      Percussion sensitivity evaluation with blunt end of a dental instrument comparing with contralateral or next healthy tooth

    2. Radiographical Evaluation [12 months]

      Integrity of lamina dura with visual evaluation of radiopaque line around the root using image plate system

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Deep dentine caries with pulp exposure
    Exclusion Criteria:
    • Pulp exposure without hemorrhage control

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry Ankara Turkey 06510

    Sponsors and Collaborators

    • Didem Sakaryali

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Didem Sakaryali, DDS, PhD, Dr, Principal investigator, Gazi University
    ClinicalTrials.gov Identifier:
    NCT03426046
    Other Study ID Numbers:
    • 1047
    First Posted:
    Feb 8, 2018
    Last Update Posted:
    Feb 12, 2018
    Last Verified:
    Feb 1, 2018
    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
    Keywords provided by Didem Sakaryali, DDS, PhD, Dr, Principal investigator, Gazi University
    Biodentine
    Cariously exposed pulp
    MTA
    Partial pulpotomy
    Image J Software
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Feb 12, 2018