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Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Primary Purpose

Caries, Dental Pulp Exposure

Status
Completed
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Mineral trioxide aggregate
Calcium hydroxide
Biodentine
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries focused on measuring dentin substitute, vital pulp therapy, Biodentine, caries

Eligibility Criteria

7 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy patients
  • Patients with at least one full or partial tooth root development
  • Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
  • Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
  • Teeth that have pulp exposure not exceeding 1 mm in size.

Exclusion Criteria:

  • Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
  • Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .

Sites / Locations

  • Centro de Salud de San Bernardo Universidad de Los Andes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Mineral trioxide aggregate (MTA)

Calcium hydroxide

Biodentine

Arm Description

Mineral trioxide aggregate Root canal repair material

-material for pulp capping

Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping

Outcomes

Primary Outcome Measures

Treatment Outcome
vitality test with electric device cold and hot test radiographic evaluation

Secondary Outcome Measures

Adverse Effects
Name any adverse effects.

Full Information

First Posted
May 27, 2015
Last Updated
May 1, 2017
Sponsor
Universidad de los Andes, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02492841
Brief Title
Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth
Official Title
Controlled Clinical Trial of the Effect of Calcium Hydroxide, Mineral Trioxide Aggregate (MTA) and Biodentine (Trademark) as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries, in Children From 7 to 16 Years
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de los Andes, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation. Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.
Detailed Description
Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental Pulp Exposure
Keywords
dentin substitute, vital pulp therapy, Biodentine, caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mineral trioxide aggregate (MTA)
Arm Type
Experimental
Arm Description
Mineral trioxide aggregate Root canal repair material
Arm Title
Calcium hydroxide
Arm Type
Active Comparator
Arm Description
-material for pulp capping
Arm Title
Biodentine
Arm Type
Experimental
Arm Description
Is a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Intervention Type
Drug
Intervention Name(s)
Mineral trioxide aggregate
Other Intervention Name(s)
MTA Pro Root
Intervention Description
Mineral trioxide aggregate
Intervention Type
Drug
Intervention Name(s)
Calcium hydroxide
Other Intervention Name(s)
Calcium hydroxide Hertz
Intervention Description
Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
Intervention Type
Drug
Intervention Name(s)
Biodentine
Other Intervention Name(s)
Active biosilicate. Septodont.
Intervention Description
Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Primary Outcome Measure Information:
Title
Treatment Outcome
Description
vitality test with electric device cold and hot test radiographic evaluation
Time Frame
3 months, 6 moths and 12 months
Secondary Outcome Measure Information:
Title
Adverse Effects
Description
Name any adverse effects.
Time Frame
1 week, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Systemically healthy patients Patients with at least one full or partial tooth root development Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration Teeth that have pulp exposure not exceeding 1 mm in size. Exclusion Criteria: Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Brizuela
Organizational Affiliation
Universidad de Los Andes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud de San Bernardo Universidad de Los Andes
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20478462
Citation
Paranjpe A, Zhang H, Johnson JD. Effects of mineral trioxide aggregate on human dental pulp cells after pulp-capping procedures. J Endod. 2010 Jun;36(6):1042-7. doi: 10.1016/j.joen.2010.02.013. Epub 2010 Mar 15.
Results Reference
background
PubMed Identifier
22251035
Citation
Leye Benoist F, Gaye Ndiaye F, Kane AW, Benoist HM, Farge P. Evaluation of mineral trioxide aggregate (MTA) versus calcium hydroxide cement (Dycal((R)) ) in the formation of a dentine bridge: a randomised controlled trial. Int Dent J. 2012 Feb;62(1):33-9. doi: 10.1111/j.1875-595X.2011.00084.x.
Results Reference
background
PubMed Identifier
23683272
Citation
Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
Results Reference
background

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Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

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