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

Patients With Deep Carious Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803528
• Other study ID #: UDDS-OperDent-01-2016
• Status: Completed
• Phase: N/A
• First received: June 14, 2016
• Last updated: December 31, 2017
• Start date: January 2015
• Est. completion date: October 20, 2017

Study information

• Verified date: December 2017
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dental Caries
• Patients With Deep Carious Lesions

Intervention

Drug:
• Biodentine
Biodentine is going to be used as the direct pulp capping material
• MTA
MTA is going to be used as the direct pulp capping material in the second group

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Operative Dentistry, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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