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Trial record 74 of 1201 for:    tooth decay

Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Direct Pulp Capping

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ClinicalTrials.gov Identifier: NCT02803528
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:
Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.

Condition or disease Intervention/treatment Phase
Patients With Deep Carious Lesions 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 Direct Pulp Capping of Deeply Carious Teeth.
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biodentine
The exposed area of the pulp is going to be covered with Biodentine.
Drug: Biodentine
Biodentine is going to be used as the direct pulp capping material

Active Comparator: MTA
The exposed area of the pulp is going to be covered with MTA
Drug: MTA
MTA is going to be used as the direct pulp capping material in the second group




Primary Outcome Measures :
  1. Success at 3 months following capping [ 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 tooth are sound 100%.

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

  3. Success at 9 months following capping [ 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 tooth are sound 100%.

  4. Success at 12 months following capping [ 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 tooth are sound 100%.

  5. Success at 18 months following capping [ 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 tooth are sound 100%.

  6. Success at 24 months following capping [ 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 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. asymptomatic vital molars (upper or lower)
  2. with complete formation of roots
  3. Aged 15 to 30 years.
  4. Accidental point pulp exposure during the process of removing dental caries.

Exclusion Criteria:

  1. If the molar not vital.
  2. If the molar is symptomatic.
  3. Immature molar.
  4. Patient not in age between (15-30 years).

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): NCT02803528


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: NCT02803528     History of Changes
Other Study ID Numbers: UDDS-OperDent-01-2016
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

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases