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NCT06122805NARecruitingAccepts Healthy Volunteers

Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery

Children's Hospital Los Angeles

Start Date

3/11/2024

Completion Date

11/30/2027

Summary

The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery. Patients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.

Detailed Description

Pilot Study, Randomized Control Clinical Trial, study groups 1) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing orthognathic surgery . 2) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing bone-graft surgery 3) Craniofacial and/or unilateral and bilateral cleft palate patients with no pending surgery. Three Investigational device include Dual Light Therapy Sonic Toothbrush (BristlTM Toothbrush), Sonic Toothbrush(BRistlTM) and manual toothbrush to target disease gingivitis in 189 patients. Categorical variables scored from Plaque Index and Gingival Index will be analyzed using Fisher exact test and McNemar test. Parametric methods will be used to analyze data from Bleeding on Probing and Periodontal Probing Depth. To determine differences between groups and within each test at all time points, Student t-test will be used.

Eligibility Criteria

Age Range: 6 years to 20 years

Inclusion Criteria: * Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles * Between the ages of 6 and 20 years * Physical status of ASA I or II * Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Exclusion Criteria: * physical inability to brush teeth * cognitive inability to comprehend and follow directions.

Interventions

DEVICE

Toothbrush

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Conditions

ToothbrushingGingivitisCleft Lip and Palate

Locations

Chilldren's Hospital Los Angeles

Los Angeles, California 90027

United States