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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 January 2018
Main ID:  NCT02803528
Date of registration: 14/06/2016
Prospective Registration: No
Primary sponsor: Damascus University
Public title: Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Direct Pulp Capping
Scientific title: A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Direct Pulp Capping of Deeply Carious Teeth.
Date of first enrolment: January 2015
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02803528
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Syrian Arab Republic
Contacts
Name:     Souad Abboud, DDS MSc PhD
Address: 
Telephone:
Email:
Affiliation:  Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria
Name:     Mohammad MN Aldakak, DDS MSc
Address: 
Telephone:
Email:
Affiliation:  PhD Student in Operative Dentistry
Key inclusion & exclusion 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).



Age minimum: 15 Years
Age maximum: 30 Years
Gender: All
Health Condition(s) or Problem(s) studied
Patients With Deep Carious Lesions
Intervention(s)
Drug: Biodentine
Drug: MTA
Primary Outcome(s)
Success at 24 months following capping [Time Frame: the success of treatment is assessed at 24 months following the application of the material]
Success at 6 months following capping [Time Frame: the success of treatment is assessed at six months following the application of the material]
Success at 12 months following capping [Time Frame: the success of treatment is assessed at 12 months following the application of the material]
Success at 3 months following capping [Time Frame: the success of treatment is assessed at three months following the application of the material]
Success at 18 months following capping [Time Frame: the success of treatment is assessed at 18 months following the application of the material]
Success at 9 months following capping [Time Frame: the success of treatment is assessed at 9 months following the application of the material]
Secondary Outcome(s)
Secondary ID(s)
UDDS-OperDent-01-2016
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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