RecruitingNot Applicable

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

United States198 participantsStarted 2024-03-11

Plain-language 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.

Who can participate

Age range

6 Years – 20 Years

Sex

ALL

See this in plain English?

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

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Löe and Silness Gingival Index

Timeframe: 18 weeks, 6 weeks apart evaluations

Bleeding index

Timeframe: 18 weeks, 6 weeks apart evaluations

Trial details

NCT IDNCT06122805

SponsorChildren's Hospital Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Stephen Yen, DMD, PhD

3233612130 syen@chla.usc.edu

View on ClinicalTrials.gov More Toothbrushing trials