Clinical trial NCT02805101: Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations
Official title: A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Sealing Root Perforations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Perforation at the Bifurcation Area
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Success at 3 months following root sealing
timeFrame: The success of treatment is assessed at three months following the application of the material
measure: Success at 6 months following root sealing
timeFrame: The success of treatment is assessed at 6 months following the application of the material
measure: Success at 9 months following root sealing
timeFrame: The success of treatment is assessed at 9 months following the application of the material
measure: Success at 12 months following root sealing
timeFrame: The success of treatment is assessed at 12 months following the application of the material
measure: Success at 18 months following root sealing
timeFrame: The success of treatment is assessed at 18 months following the application of the material
measure: Success at 24 months following root sealing
timeFrame: The success of treatment is assessed at 24 months following the application of the material
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Operative Dentistry, University of Damascus Dental School
Study officials:
affiliation: PhD Student in Operative Dentistry
name: Mohammad MN Aldakak, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria
name: Souad Abboud, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.