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Comparison of The Success Rates of Four Different Pulpotomy Techniques

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT03135626
Collaborator
(none)
38
Enrollment
4
Arms
35.1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.

Condition or Disease Intervention/Treatment Phase
  • Drug: Biodentine
  • Drug: ProRoot (Aggregate)
  • Drug: MTA Plus
  • Drug: Ferric Sulfate 20 % Dental Gel
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Split-mouth study design was usedSplit-mouth study design was used
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of The Success Rates of Four Different Pulpotomy Techniques
Actual Study Start Date :
Mar 15, 2013
Actual Primary Completion Date :
Jan 15, 2014
Actual Study Completion Date :
Feb 15, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biodentine

Biodentine pulpotomy agent

Drug: Biodentine
Other Names:
  • 77509635

    		•
    Experimental: ProRoot MTA

    ProRoot MTA pulpotomy agent

    Drug: ProRoot (Aggregate)
    Other Names:
  • 75896452

    		•
    Experimental: MTA Plus

    MTA Plus pulpotomy agent

    Drug: MTA Plus
    Other Names:
  • 85303191

    		•
    Active Comparator: Ferric Sulfate 20% Dental Gel

    Ferric Sulfate %20 Dental Gel pulpotomy agent

    Drug: Ferric Sulfate 20 % Dental Gel
    Other Names:
  • Viscostat

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total success rate [6 months after pulpotomy treatment]

      Number of molars with both clinically and radiographically successful

    2. Total success rate [12 months after pulpotomy treatment]

      Number of molars with both clinically and radiographically successful

    3. Total success rate [24 months after pulpotomy treatment]

      Number of molars with both clinically and radiographically successful

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.
    Exclusion Criteria:
    • The exclusion criteria were the presence of any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Principal Investigator: Yeliz Guven, Dr., Istanbul University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yeliz Guven, Dr, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT03135626
    Other Study ID Numbers:
    • 2012/1728-1288
    First Posted:
    May 1, 2017
    Last Update Posted:
    May 1, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yeliz Guven, Dr, Istanbul University
    Pulpotomy
    Primary molars

    Study Results

    No Results Posted as of May 1, 2017