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Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805101
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:
This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two materials are going to be tested in sealing accidental root perforations at the bifurcation areas. The study is going to be conducted as a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Root Perforation at the Bifurcation Area Drug: Biodentine Drug: MTA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.
Study Start Date : January 2015
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Experimental: Biodentine
The perforation area of the root is going to be covered by Biodentine
Drug: Biodentine
Biodentine is going to be used as the sealing agent for the perforation.

Active Comparator: MTA
The perforation area of the root is going to be covered by MTA.
Drug: MTA
MTA is going to be used as the sealing agent for the perforation.




Primary Outcome Measures :
  1. Success at 3 months following root sealing [ Time Frame: The success of treatment is assessed at three months following the application of the material ]
    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  2. Success at 6 months following root sealing [ Time Frame: The success of treatment is assessed at 6 months following the application of the material ]
    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  3. Success at 9 months following root sealing [ Time Frame: The success of treatment is assessed at 9 months following the application of the material ]
    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  4. Success at 12 months following root sealing [ Time Frame: The success of treatment is assessed at 12 months following the application of the material ]
    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  5. Success at 18 months following root sealing [ Time Frame: The success of treatment is assessed at 18 months following the application of the material ]
    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.

  6. Success at 24 months following root sealing [ Time Frame: The success of treatment is assessed at 24 months following the application of the material ]
    Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.



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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. vital molars (upper or lower )
  2. suffered from perforation in the bifurcation area of the roots through a process of open access cavity, taking into account the location and size of perforation
  3. Perforation should not exceed the size of 3 mm
  4. Perforation and must also take into account the time of perforation.

Exclusion Criteria:

  1. If the molar not vital.
  2. If the perforation not in bifurcation root or extended inside the canals.
  3. Size of perforation larger than 3 mm.
  4. A long time ago on the occurrence of perforation with resorption in tooth structure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805101


Locations
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Syrian Arab Republic
Department of Operative Dentistry, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Mohammad MN Aldakak, DDS MSc PhD Student in Operative Dentistry
Study Chair: Souad Abboud, DDS MSc PhD Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria
Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02805101    
Other Study ID Numbers: UDDS-OperDent-02-2016
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No