Gingivitis Clinical Trial
Official title:
Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
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.
Status | Recruiting |
Enrollment | 198 |
Est. completion date | November 30, 2027 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 20 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Chilldren's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Löe and Silness Gingival Index | This involves a two-step process: Step One (1): evaluation of the clinical appearance of the gingival tissue; and Step Two (2): assessment of inflammation based on induction of bleeding from probing11. Step One will not be accomplished chairside but will be measured using photographs; Step Two will be done chairside. | 18 weeks, 6 weeks apart evaluations | |
Primary | Bleeding index | For Bleeding Index (Appendix IIC) and measurement of Probing Depth, the scorers will be calibrated following the Examiner Guide to Measuring Periodontal Parameters & Indices11. Probing Depth will be measured using a University of North Carolina (UNC) #15 manual probe and a #5 mouth mirror | 18 weeks, 6 weeks apart evaluations | |
Secondary | Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient | After placement of five drops of Trace® plaque disclosing liquid under the tongue, the participant will swish the solution for 30 seconds. Upon expectoration, the participant will rinse his/her mouth with water three times. Immediately, intraoral photographs will be made. All photos for Gingival Index and Plaque Index will be scored by two blinded scorers with inter-rater reliability calculated. All scoring data will be assessed by statistician. | 18 weeks, 6 week apart evaluations |
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