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

NCT02803528 | Completed DMC

• 1 other identifier: UDDS-OperDent-01-2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients With Deep Carious Lesions

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Biodentine

EXPERIMENTAL

The exposed area of the pulp is going to be covered with Biodentine.

Drug: Biodentine

MTA

ACTIVE COMPARATOR

The exposed area of the pulp is going to be covered with MTA

Drug: MTA

Interventions

Biodentine DRUG

Biodentine is going to be used as the direct pulp capping material

Biodentine

MTA DRUG

MTA is going to be used as the direct pulp capping material in the second group

MTA

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• If the molar not vital.
• If the molar is symptomatic.
• Immature molar.
• Patient not in age between (15-30 years).

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Operative Dentistry, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related 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.

  PMID: 23402511 BACKGROUND

• 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.

  PMID: 16764130 BACKGROUND

• 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.

  PMID: 22411260 BACKGROUND

• 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.

  PMID: 18448160 BACKGROUND

• 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.

  PMID: 22892739 BACKGROUND

MeSH Terms

Interventions

tricalcium silicate; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Mohammad MN Aldakak, DDS MSc

  PhD Student in Operative Dentistry

  PRINCIPAL INVESTIGATOR

• Souad Abboud, DDS MSc PhD

  Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: January 1, 2015
• Primary Completion: January 20, 2017
• Study Completion: October 20, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)