Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
Children's Hospital Los Angeles
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.
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 an…
Eligibility
- Age range
- 6–20 years
- Sex
- All
- Healthy volunteers
- Yes
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
- DeviceToothbrush
We will test three toothbrushes in patients undergoing surgery and a control no surgery group. These toothbrushes are manual toothbrushes, sonic toothbrushes, and sonic and dual light toothbrushes.
Location
- Chilldren's Hospital Los AngelesLos Angeles, California