Phase 3
N=70
Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03788616 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth — 30; 32; 28; 30 primary molars — p=0.478
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fuji IX EXTRA (Drug); ACTIVA KIDS bioactive restorative material (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Marina F Fahmy, MD
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth |
30; 32; 28; 30; 26; 25 | 0.478 |
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) .
Eligibility Criteria
Inclusion Criteria
- Children aged from 4 to 8 years old, in good general health
- Children classified as class 3 or 4 based on Frankel et al. classification. (26)
- The children have at least one primary molar with class I carious lesion.
- Asymptomatic teeth (without spontaneous pain)
Exclusion Criteria
- Medically compromised patient
- Presence of pulp exposure, pain, mobility
- Presence of swelling, abscess or fistula near the tooth
- Not accessible carious lesion to hand instruments
Data sourced from ClinicalTrials.gov (NCT03788616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.