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

Not Applicable

Completed

• Conditions: Root Perforation at the Bifurcation Area
• Interventions: Drug: Biodentine; Drug: MTA

• Registration Number: NCT02805101
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-17
• Primary Completion: 2017-06-20
• Study Completion: 2017-10-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-31
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biodentine	Biodentine	The perforation area of the root is going to be covered by Biodentine
MTA	MTA	The perforation area of the root is going to be covered by MTA.

Primary Outcome Measures

Name	Time	Method
Success at 3 months following root sealing	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%.
Success at 6 months following root sealing	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%.
Success at 9 months following root sealing	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%.
Success at 12 months following root sealing	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%.
Success at 18 months following root sealing	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%.
Success at 24 months following root sealing	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%.

Trial Locations

Locations (1)

Department of Operative Dentistry, University of Damascus Dental School; 🇸🇾 Damascus, Syrian Arab Republic