At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
Fuji IX EXTRA +1 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.
Evaluation of Fluoride Release and Compressive Strength of a Bioactive Restorative Material and Its Clinical Performance in Atraumatic Restorative Treatment in Primary Molars (An in Vitro Study & A Randomized Controlled Trial )
In Brief
A Phase 3 clinical trial evaluating Fuji IX EXTRA and ACTIVA KIDS bioactive restorative material for Dental Caries. Completed, enrolled 110 participants across 1 site.
Detailed Summary
The study will be two parallel group, triple blinded randomized controlled clinical trial that based on CONSORT (consolidated standards of reporting trials) guideline .The selected participants according to inclusion and exclusion criteria will be randomly allocated in two groups using (Research Randomizer Program) .
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesEgypt
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartNov 2018
First PostedDec 2018
Primary CompletionNov 2019
TodayJul 2026
First PostedDec 27, 2018
Enrollment StartNov 17, 2018
Primary CompletionNov 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 7.5 years ago
Interventions
Fuji IX EXTRAdrug
High-viscosity glass ionomer (Fuji IX EXTRA)
ACTIVA KIDS bioactive restorative materialdrug
Modified composite (ACTIVA KIDS)