Clinical trial NCT02803528: Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Direct Pulp Capping
Official title: A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Direct Pulp Capping of Deeply Carious Teeth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Deep Carious Lesions
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: Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.


Eligibility criteria: Inclusion Criteria:

1. asymptomatic vital molars (upper or lower)
2. with complete formation of roots
3. Aged 15 to 30 years.
4. Accidental point pulp exposure during the process of removing dental caries.

Exclusion Criteria:

1. If the molar not vital.
2. If the molar is symptomatic.
3. Immature molar.
4. Patient not in age between (15-30 years).

Primary outcomes:
measure: Success at 3 months following capping
timeFrame: the success of treatment is assessed at three months following the application of the material
measure: Success at 6 months following capping
timeFrame: the success of treatment is assessed at six months following the application of the material
measure: Success at 9 months following capping
timeFrame: the success of treatment is assessed at 9 months following the application of the material
measure: Success at 12 months following capping
timeFrame: the success of treatment is assessed at 12 months following the application of the material
measure: Success at 18 months following capping
timeFrame: the success of treatment is assessed at 18 months following the application of the material
measure: Success at 24 months following capping
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.