Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery

Children's Hospital Los Angeles198 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

198

Conditions

Toothbrushing Gingivitis

Eligibility

Sex: ALLMin age: 6 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 18 weeks, 6 weeks apart evaluations

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

Time frame: 18 weeks, 6 weeks apart evaluations

Secondary Outcomes

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.

Time frame: 18 weeks, 6 week apart evaluations