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

NCT ID: NCT02805101

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-10-30

Brief Summary

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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

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Conditions

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Root Perforation at the Bifurcation Area

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Biodentine

The perforation area of the root is going to be covered by Biodentine

Group Type EXPERIMENTAL

Biodentine

Intervention Type DRUG

Biodentine is going to be used as the sealing agent for the perforation.

MTA

The perforation area of the root is going to be covered by MTA.

Group Type ACTIVE_COMPARATOR

MTA

Intervention Type DRUG

MTA is going to be used as the sealing agent for the perforation.

Interventions

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Biodentine

Biodentine is going to be used as the sealing agent for the perforation.

Intervention Type DRUG

MTA

MTA is going to be used as the sealing agent for the perforation.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad MN Aldakak, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD Student in Operative Dentistry

Souad Abboud, DDS MSc PhD

Role: STUDY_CHAIR

Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria

Locations

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Department of Operative Dentistry, University of Damascus Dental School

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 23402511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16764130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22411260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18448160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22892739 (View on PubMed)

Other Identifiers

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UDDS-OperDent-02-2016

Identifier Type: -

Identifier Source: org_study_id

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