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

A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.

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.

Study Overview

• Status: Completed
• Conditions: Root Perforation at the Bifurcation Area
• Intervention / Treatment: Drug: Biodentine; Drug: MTA

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Operative Dentistry, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success at 3 months following root sealing	Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.	The success of treatment is assessed at three months following the application of the material
Success at 6 months following root sealing	Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.	The success of treatment is assessed at 6 months following the application of the material
Success at 9 months following root sealing	Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.	The success of treatment is assessed at 9 months following the application of the material
Success at 12 months following root sealing	Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.	The success of treatment is assessed at 12 months following the application of the material
Success at 18 months following root sealing	Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.	The success of treatment is assessed at 18 months following the application of the material
Success at 24 months following root sealing	Case is considered successful if clinical and radiographic examinations of the tooth are sound 100%.	The success of treatment is assessed at 24 months following the application of the material

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: 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 and helpful links

General Publications

• Guneser MB, Akbulut MB, Eldeniz AU. Effect of various endodontic irrigants on the push-out bond strength of biodentine and conventional root perforation repair materials. J Endod. 2013 Mar;39(3):380-4. doi: 10.1016/j.joen.2012.11.033. Epub 2013 Jan 16.
• Iwamoto CE, Adachi E, Pameijer CH, Barnes D, Romberg EE, Jefferies S. Clinical and histological evaluation of white ProRoot MTA in direct pulp capping. Am J Dent. 2006 Apr;19(2):85-90.
• Koubi G, Colon P, Franquin JC, Hartmann A, Richard G, Faure MO, Lambert G. Clinical evaluation of the performance and safety of a new dentine substitute, Biodentine, in the restoration of posterior teeth - a prospective study. Clin Oral Investig. 2013 Jan;17(1):243-9. doi: 10.1007/s00784-012-0701-9. Epub 2012 Mar 14.
• Laurent P, Camps J, De Meo M, Dejou J, About I. Induction of specific cell responses to a Ca(3)SiO(5)-based posterior restorative material. Dent Mater. 2008 Nov;24(11):1486-94. doi: 10.1016/j.dental.2008.02.020. Epub 2008 Apr 29.
• Zanini M, Sautier JM, Berdal A, Simon S. Biodentine induces immortalized murine pulp cell differentiation into odontoblast-like cells and stimulates biomineralization. J Endod. 2012 Sep;38(9):1220-6. doi: 10.1016/j.joen.2012.04.018. Epub 2012 Jul 24.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 20, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 31, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: UDDS-OperDent-02-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No