CompletedNot Applicable

A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants

United States104 participantsStarted 2015-02

Plain-language summary

The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

Who can participate

Age range6 Years – 16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy patients: American Society of Anesthesiologists (ASA) I or II * Good cooperation: Frank1 3 or 4 * Aged between 6-16 years old at the day of sealant placement * Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars. Exclusion Criteria: * Teeth with a history of past or current caries * Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies * Teeth with clinical or radiographic evidence of pathology * Teeth with a history of restoration or sealant * Patients who are poorly behaved

What they're measuring

Sealant Retention Percentage at 12 Months After Treatment

Timeframe: 12 months after treatment

Trial details

NCT IDNCT02668874

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-21

Results submitted2019-05-14

View on ClinicalTrials.gov More Dental Caries on Pit and Fissure Surface trials