Comparing electric and manual toothbrushes for orthodontic patients after oral surgery
Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
This study tests whether an electric toothbrush works better than a manual toothbrush for improving gum health in orthodontic patients who have had oral surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 6 Years to 20 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06122805 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a dual light ultrasonic toothbrush compared to a manual toothbrush in improving periodontal health among orthodontic patients undergoing oral surgery, specifically those with cleft lip and palate. The study involves a randomized control design with three groups: patients undergoing orthognathic surgery, those undergoing bone-graft surgery, and patients without pending surgery. The trial will assess periodontal outcomes using various indices and statistical methods to analyze the data collected from 189 participants.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6 to 20 years with a diagnosis of craniofacial and/or cleft lip and palate who are receiving care at the Children's Hospital Los Angeles.
Not a fit: Patients who are physically or cognitively unable to brush their teeth will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oral health outcomes for orthodontic patients recovering from surgery.
How similar studies have performed: While this approach is relatively novel, previous studies have indicated that improved oral hygiene methods can positively impact periodontal health in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California
- Chilldren's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Yen, DMD, PhD — Children's Hospital Los Angeles and USC
- Study coordinator: Stephen Yen, DMD, PhD
- Email: syen@chla.usc.edu
- Phone: 3233612130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.