Clinical trial NCT06122805: Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery
Official title: Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Toothbrushing
Gingivitis
Cleft Lip and Palate
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 198
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: PREVENTION

Brief 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.

Detailed 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 and Gingival Index will be analyzed using Fisher exact test and McNemar test. Parametric methods will be used to analyze data from Bleeding on Probing and Periodontal Probing Depth. To determine differences between groups and within each test at all time points, Student t-test will be used.

Eligibility 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.

Primary outcomes:
measure: Löe and Silness Gingival Index
timeFrame: 18 weeks, 6 weeks apart evaluations
measure: Bleeding index
timeFrame: 18 weeks, 6 weeks apart evaluations
Secondary outcomes:
measure: Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient
timeFrame: 18 weeks, 6 week apart evaluations
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Chilldren's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles and USC
name: Stephen Yen, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ccahuana-Vasquez RA, Conde E, Grender JM, Cunningham P, Qaqish J, Goyal CR. An Eight-Week Clinical Evaluation of an Oscillating-Rotating Power Toothbrush with a Brush Head Utilizing Angled Bristles Compared with a Sonic Toothbrush in the Reduction of Gingivitis and Plaque. J Clin Dent. 2015;26(3):80-5.