CompletedPhase 3

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

Egypt110 participantsStarted 2018-11-17

Plain-language 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) .

Who can participate

Age range4 Years – 8 Years

SexALL

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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

What they're measuring

the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth

Timeframe: 12 Month

Trial details

NCT IDNCT03788616

SponsorMarina F Fahmy, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-17

Results submitted2021-11-06

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