Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth
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
2 other identifiers
interventional
169
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
August 14, 2017
CompletedMay 30, 2024
May 1, 2024
2 years
May 27, 2015
May 1, 2017
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parameters Evaluated After Treatment
vitality test with electric device cold and hot test radiographic evaluation
3 months, 6 moths and 12 months
Secondary Outcomes (1)
Number of Participants With Adverse Effects
1 week, 3 and 6 months
Study Arms (3)
Mineral trioxide aggregate (MTA)
EXPERIMENTALMineral trioxide aggregate Root canal repair material
Calcium hydroxide
ACTIVE COMPARATOR-material for pulp capping
Biodentine
EXPERIMENTALIs a calcium-silicate based materia root perforations, apexification, resorptive lesions, and retrograde filling material in endodontic surgery, pulp capping
Interventions
Mineral trioxide aggregate
Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro de Salud de San Bernardo Universidad de Los Andes
Santiago, Chile
Related Publications (3)
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.
PMID: 20478462BACKGROUNDLeye 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.
PMID: 22251035BACKGROUNDNowicka 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.
PMID: 23683272BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The small sample due to inclusion criteria. Lack of collaboration from the primary health providers. And the fact that the oral health seems not to be a priority and people only come when it hurts and it is too late for prevention.
Results Point of Contact
- Title
- Dra. CLAUDIA BRIZUELA CORDERO
- Organization
- UNIVERSIDAD DE LOS ANDES
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia Brizuela
Universidad de Los Andes
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS
Study Record Dates
First Submitted
May 27, 2015
First Posted
July 9, 2015
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
August 1, 2016
Last Updated
May 30, 2024
Results First Posted
August 14, 2017
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share