Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 20
Healthy Volunteers: t
View:
• 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
Locations
United States
California
Chilldren's Hospital Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Stephen Yen, DMD, PhD
syen@chla.usc.edu
3233612130
Backup
Jose Polido, DDS
jpolido@chla.usc.edu
3233612130
Time Frame
Start Date: 2024-03-11
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 198
Treatments
Experimental: Orthognathic Surgery Manual Toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention: Manual toothbrush.
Experimental: Orthognathic Surgery Sonic toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention:Sonic toothbrush without activation of the dual light feature.
Experimental: Orthognathic Surgery Sonic and dual light toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention:Sonic toothbrush with activation of the dual light feature
Experimental: Bone Graft Manual Toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention:Manual toothbrush.
Experimental: Bone Graft Sonic Toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention:Sonic toothbrush without activation of the dual light feature.
Experimental: Bone Graft Sonic and Dual-light Toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention:Sonic toothbrush with activation of the dual light feature
Experimental: No surgery, Manual Toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5, Intervention:Manual toothbrush.
Experimental: No Surgery, Sonic Toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention:Sonic toothbrush without activation of the dual light feature.
Experimental: No Surgery, Sonic and Dual-light Toothbrush
1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles~2. Between the ages of 6 and 20 years~3. Physical status of ASA I or II~4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate~5. Intervention:Sonic toothbrush with activation of the dual light feature
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Los Angeles