Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Direct Pulp Capping

A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Direct Pulp Capping of Deeply Carious Teeth.

Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.

Study Overview

• Status: Completed
• Conditions: Patients With Deep Carious Lesions
• Intervention / Treatment: Drug: Biodentine; Drug: MTA

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of Operative Dentistry, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biodentine; The exposed area of the pulp is going to be covered with Biodentine.	Drug: Biodentine; Biodentine is going to be used as the direct pulp capping material
Active Comparator: MTA; The exposed area of the pulp is going to be covered with MTA	Drug: MTA; MTA is going to be used as the direct pulp capping material in the second group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success at 3 months following capping	Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.	the success of treatment is assessed at three months following the application of the material
Success at 6 months following capping	Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.	the success of treatment is assessed at six months following the application of the material
Success at 9 months following capping	Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.	the success of treatment is assessed at 9 months following the application of the material
Success at 12 months following capping	Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.	the success of treatment is assessed at 12 months following the application of the material
Success at 18 months following capping	Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.	the success of treatment is assessed at 18 months following the application of the material
Success at 24 months following capping	Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.	the success of treatment is assessed at 24 months following the application of the material

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 20, 2017
• Study Completion (Actual): October 20, 2017

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 31, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: UDDS-OperDent-01-2016

Plan for Individual participant data (IPD)

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