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Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART

NCT03788616 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-01-19

Study results available
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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) .

Conditions

  • Dental Caries

Interventions

DRUG

Fuji IX EXTRA

High-viscosity glass ionomer (Fuji IX EXTRA)

DRUG

ACTIVA KIDS bioactive restorative material

Modified composite (ACTIVA KIDS)

Sponsors & Collaborators

  • Marina F Fahmy, MD

    lead OTHER

Principal Investigators

  • Amr Mahmoud Abd EL Aziz · Professor of Pediatric Dentistry and Dental Public Health Department -ASU

  • Reham Khaled Abou El Fadl · Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-17
Primary Completion
2019-11-17
Completion
2019-11-17
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03788616 on ClinicalTrials.gov