Toothbrushing, Gingivitis, Cleft Lip and Palate
Conditions
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.
Interventions
DEVICEToothbrush
We will test three toothbrushes in patients undergoing surgery and a control no surgery group. These toothbrushes are manual toothbrushes, sonic toothbrushes, and sonic and dual light toothbrushes.
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
randomized assignment of study ID number
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Löe and Silness Gingival Index | 18 weeks, 6 weeks apart evaluations | 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. |
| Bleeding index | 18 weeks, 6 weeks apart evaluations | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient | 18 weeks, 6 week apart evaluations | 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. |
Countries
United States
Contacts
Primary ContactStephen Yen, DMD, PhD
Backup ContactJose Polido, DDS
Outcome results
None listed