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

NCT02805101 | Completed DMC

• 1 other identifier: UDDS-OperDent-02-2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Root Perforation at the Bifurcation Area

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Biodentine

EXPERIMENTAL

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

Drug: Biodentine

MTA

ACTIVE COMPARATOR

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

Drug: MTA

Interventions

Biodentine DRUG

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

Biodentine

MTA DRUG

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

MTA

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• vital molars (upper or lower )
• 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
• Perforation should not exceed the size of 3 mm
• Perforation and must also take into account the time of perforation.

You may not qualify if:

• If the molar not vital.
• If the perforation not in bifurcation root or extended inside the canals.
• Size of perforation larger than 3 mm.
• A long time ago on the occurrence of perforation with resorption in tooth structure.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Operative Dentistry, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (5)

• 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.

  PMID: 23402511 BACKGROUND

• 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.

  PMID: 16764130 BACKGROUND

• 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.

  PMID: 22411260 BACKGROUND

• 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.

  PMID: 18448160 BACKGROUND

• 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.

  PMID: 22892739 BACKGROUND

MeSH Terms

Interventions

tricalcium silicate; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Mohammad MN Aldakak, DDS MSc

  PhD Student in Operative Dentistry

  PRINCIPAL INVESTIGATOR

• Souad Abboud, DDS MSc PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 17, 2016
• Study Start: January 1, 2015
• Primary Completion: June 20, 2017
• Study Completion: October 30, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)