Actively Recruiting
Effectiveness of Dual Light Therapy Electric Toothbrush vs. Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
Led by Children's Hospital Los Angeles · Updated on 2024-05-13
198
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of different types of toothbrushes on the oral health of orthodontic patients with cleft lip and palate who are undergoing surgery. This study focuses on comparing periodontal health outcomes among patients receiving orthognathic surgery, bone graft surgery, or no surgery. It is a randomized clinical trial involving 189 patients to assess how well these toothbrushes manage gingivitis during the post-surgical period. The study tests three toothbrush types: a manual toothbrush, a sonic toothbrush, and a sonic toothbrush with a dual light feature. Patients are divided into groups based on their surgery type and the toothbrush used. The trial includes patients who are between 6 and 20 years old and are patients at a specialized orthodontic clinic. The study will analyze periodontal health using various indices such as the Plaque Index, Gingival Index, Bleeding on Probing, and Periodontal Probing Depth over 18 weeks with evaluations every six weeks. Participants will be monitored at several time points for periodontal outcomes including gingival inflammation and bleeding. The study collects data through clinical assessments scoring plaque and gingival health. Researchers will also track bleeding and probing depths to measure the effectiveness of each toothbrush type. The total observation period is 18 weeks, during which participants' oral health will be closely assessed and compared across the different treatment groups.
CONDITIONS
Brief Title
Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Physical inability to brush teeth
- Cognitive inability to comprehend and follow directions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 weeks
Participants use one of three types of toothbrushes: manual, sonic, or sonic with dual light therapy. This occurs across groups with and without oral surgery.
Visits every 6 weeks for evaluations
Trial Site Locations
Total: 1 location
1
Chilldren's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
Research Team
S
Stephen Yen, DMD, PhD
J
Jose Polido, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
9