Clincosm LogoSign in Get a demo

Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT03395496
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
37
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
Actual Study Start Date :
May 1, 2013
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biodentine

Dental materials

Drug: Biodentine
Biodentine pulpotomy agent
Other Names:
  • 77509635

    • Drug: ProRoot (Aggregate)
    ProRoot MTA pulpotomy agent
    Other Names:
  • 75896452

    		•
    Experimental: ProRoot MTA

    Dental Materials

    Drug: Biodentine
    Biodentine pulpotomy agent
    Other Names:
  • 77509635

    • Drug: ProRoot (Aggregate)
    ProRoot MTA pulpotomy agent
    Other Names:
  • 75896452

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Other Outcome Measures

    1. Total success rate [36 months after pulpotomy treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • no clinical and radiographic evidence of pulp pathology,

    • no clinical and radiographic symptoms,

    • no history of spontaneous pain and tenderness,

    • no percussion, swelling or sinus tracts and pathologic mobility.

    Exclusion Criteria:

    • 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)

    • furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.

    • without permanent successor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University Istanbul Turkey 34093

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mine Koruyucu, Principal Investigator, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT03395496
    Other Study ID Numbers:
    • 2017-24692
    First Posted:
    Jan 10, 2018
    Last Update Posted:
    Jan 10, 2018
    Last Verified:
    Jan 1, 2018
    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
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Mine Koruyucu, Principal Investigator, Istanbul University
    pulpotomy
    pediatric dentistry
    primary molars
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Jan 10, 2018