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Register:	ClinicalTrials.gov
Last refreshed on:	8 January 2018
Main ID:	NCT02805101
Date of registration:	15/06/2016
Prospective Registration:	No
Primary sponsor:	Damascus University
Public title:	Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations
Scientific title:	A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.
Date of first enrolment:	January 2015
Target sample size:	30
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02805101
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. 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.

Age minimum: 15 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Root Perforation at the Bifurcation Area

Intervention(s)

Drug: MTA

Drug: Biodentine

Primary Outcome(s)

Success at 12 months following root sealing [Time Frame: The success of treatment is assessed at 12 months following the application of the material]

Success at 24 months following root sealing [Time Frame: The success of treatment is assessed at 24 months following the application of the material]

Success at 18 months following root sealing [Time Frame: The success of treatment is assessed at 18 months following the application of the material]

Success at 3 months following root sealing [Time Frame: The success of treatment is assessed at three months following the application of the material]

Success at 6 months following root sealing [Time Frame: The success of treatment is assessed at 6 months following the application of the material]

Success at 9 months following root sealing [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-02-2016

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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