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

Primary Purpose

Patients With Deep Carious Lesions

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Biodentine
MTA
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Deep Carious Lesions

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Operative Dentistry, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biodentine

MTA

Arm Description

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

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

Outcomes

Primary Outcome Measures

Success at 3 months following capping
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Success at 6 months following capping
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Success at 9 months following capping
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Success at 12 months following capping
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Success at 18 months following capping
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Success at 24 months following capping
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2016
Last Updated
December 31, 2017
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02803528
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Deep Carious Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biodentine
Arm Type
Experimental
Arm Description
The exposed area of the pulp is going to be covered with Biodentine.
Arm Title
MTA
Arm Type
Active Comparator
Arm Description
The exposed area of the pulp is going to be covered with MTA
Intervention Type
Drug
Intervention Name(s)
Biodentine
Intervention Description
Biodentine is going to be used as the direct pulp capping material
Intervention Type
Drug
Intervention Name(s)
MTA
Intervention Description
MTA is going to be used as the direct pulp capping material in the second group
Primary Outcome Measure Information:
Title
Success at 3 months following capping
Description
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Time Frame
the success of treatment is assessed at three months following the application of the material
Title
Success at 6 months following capping
Description
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Time Frame
the success of treatment is assessed at six months following the application of the material
Title
Success at 9 months following capping
Description
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Time Frame
the success of treatment is assessed at 9 months following the application of the material
Title
Success at 12 months following capping
Description
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Time Frame
the success of treatment is assessed at 12 months following the application of the material
Title
Success at 18 months following capping
Description
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Time Frame
the success of treatment is assessed at 18 months following the application of the material
Title
Success at 24 months following capping
Description
Case is considered successful if clinical and radiographic examinations of tooth are sound 100%.
Time Frame
the success of treatment is assessed at 24 months following the application of the material

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: If the molar not vital. If the molar is symptomatic. Immature molar. Patient not in age between (15-30 years).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad MN Aldakak, DDS MSc
Organizational Affiliation
PhD Student in Operative Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Souad Abboud, DDS MSc PhD
Organizational Affiliation
Associate Professor of Operative Dentistry, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Operative Dentistry, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23402511
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.
Results Reference
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PubMed Identifier
16764130
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.
Results Reference
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PubMed Identifier
22411260
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.
Results Reference
background
PubMed Identifier
18448160
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.
Results Reference
background
PubMed Identifier
22892739
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.
Results Reference
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Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Direct Pulp Capping

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