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

Study Overview
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Brief Summary
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We are conducting 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. We will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.

Detailed Description
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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.

Official Title
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Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery

Conditions
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Toothbrushing, Gingivitis, Cleft Lip and Palate

Intervention / Treatment
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* Device: Toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: physical inability to brush teeth cognitive inability to comprehend and follow directions.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthognathic Surgery Manual Toothbrush<br>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 Intervention: Manual toothbrush. | Device: Toothbrush<br>* 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.<br>|
| Experimental: Orthognathic Surgery Sonic toothbrush<br>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 Intervention:Sonic toothbrush without activation of the dual light feature. | Device: Toothbrush<br>* 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.<br>|
| Experimental: Orthognathic Surgery Sonic and dual light toothbrush<br>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 Intervention:Sonic toothbrush with activation of the dual light feature | Device: Toothbrush<br>* 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.<br>|
| Experimental: Bone Graft Manual Toothbrush<br>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 Intervention:Manual toothbrush. | Device: Toothbrush<br>* 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.<br>|
| Experimental: Bone Graft Sonic Toothbrush<br>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 Intervention:Sonic toothbrush without activation of the dual light feature. | Device: Toothbrush<br>* 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.<br>|
| Experimental: Bone Graft Sonic and Dual-light Toothbrush<br>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 Intervention:Sonic toothbrush with activation of the dual light feature | Device: Toothbrush<br>* 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.<br>|
| Experimental: No surgery, Manual Toothbrush<br>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 5, Intervention:Manual toothbrush. | Device: Toothbrush<br>* 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.<br>|
| Experimental: No Surgery, Sonic Toothbrush<br>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 Intervention:Sonic toothbrush without activation of the dual light feature. | Device: Toothbrush<br>* 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.<br>|
| Experimental: No Surgery, Sonic and Dual-light Toothbrush<br>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 Intervention:Sonic toothbrush with activation of the dual light feature | Device: Toothbrush<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |