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

• Sponsor: Damascus University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02805101
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 33.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Root Perforation at the Bifurcation Area	Drug: Biodentine; Drug: MTA	N/A

Study Design

• Study Type: Interventional
• 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 Sealing Root Perforations.
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jun 20, 2017
• Actual Study Completion Date: Oct 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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%.

2. 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%.

3. 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%.

4. 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%.

5. 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%.

6. 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%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Operative Dentistry, University of Damascus Dental School	Damascus		Syrian Arab Republic	DM20AM18

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

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 Méo M, Déjou 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.

• Responsible Party: Damascus University
• ClinicalTrials.gov Identifier: NCT02805101
• Other Study ID Numbers: UDDS-OperDent-02-2016
• First Posted: Jun 17, 2016
• Last Update Posted: Jan 3, 2018
• Last Verified: Dec 1, 2017

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

Study Results

No Results Posted as of Jan 3, 2018