CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 169 enrolled
Drug / intervention
Mineral trioxide aggregate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02492841
NCT02492841Phase 3Completed

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

Universidad de los Andes, Chile·interventional·Posted Jul 9, 2015·Updated May 30, 2024

In Brief

A Phase 3 clinical trial evaluating Mineral trioxide aggregate, Calcium hydroxide, and 1 other intervention for Caries and Dental Pulp Exposure. Completed, enrolled 169 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 9, 2015
Enrollment StartApr 1, 2014
Primary CompletionApr 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.0 years ago

Interventions

Mineral trioxide aggregatedrug

Mineral trioxide aggregate

Calcium hydroxidedrug

Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.

Biodentinedrug

Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.