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

• Sponsor: Damascus University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02803528
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patients With Deep Carious Lesions	Drug: Biodentine; Drug: MTA	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of the Performance of Biodentine and Mineral Trioxide Aggregate (MTA) in Direct Pulp Capping of Deeply Carious Teeth.
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jan 20, 2017
• Actual Study Completion Date: Oct 20, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Success at 3 months following capping [the success of treatment is assessed at three months following the application of the material]

   Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.

2. Success at 6 months following capping [the success of treatment is assessed at six months following the application of the material]

   Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.

3. Success at 9 months following capping [the success of treatment is assessed at 9 months following the application of the material]

   Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.

4. Success at 12 months following capping [the success of treatment is assessed at 12 months following the application of the material]

   Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.

5. Success at 18 months following capping [the success of treatment is assessed at 18 months following the application of the material]

   Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.

6. Success at 24 months following capping [the success of treatment is assessed at 24 months following the application of the material]

   Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Operative Dentistry, University of Damascus Dental School	Damascus		Syrian Arab Republic	DM20AM18

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

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 Méo M, Déjou 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.

• Responsible Party: Damascus University
• ClinicalTrials.gov Identifier: NCT02803528
• Other Study ID Numbers: UDDS-OperDent-01-2016
• First Posted: Jun 17, 2016
• Last Update Posted: Jan 3, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Jan 3, 2018