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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06122805
Study type Interventional
Source Children's Hospital Los Angeles
Contact Stephen Yen, DMD, PhD
Phone 3233612130
Email syen@chla.usc.edu
Status Recruiting
Phase N/A
Start date March 11, 2024
Completion date November 30, 2027

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