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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingivitis; Cleft Lip and Palate; Toothbrushing
• Intervention / Treatment: Device: Toothbrush

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.

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Yen, DMD, PhD; Phone Number: 3233612130; Email: syen@chla.usc.edu
• Study Contact Backup: Name: Jose Polido, DDS; Phone Number: 3233612130; Email: jpolido@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Chilldren's Hospital Los Angeles
      • Contact: Stephen Yen; Phone Number: 323-361-2130; Email: syen@chla.usc.edu
      • Contact: Jose Polido; Phone Number: 3233612130; Email: jpolido@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orthognathic Surgery Manual Toothbrush; 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; 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.
Experimental: Orthognathic Surgery Sonic toothbrush; 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; 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.
Experimental: Orthognathic Surgery Sonic and dual light toothbrush; 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; 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.
Experimental: Bone Graft Manual Toothbrush; 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; 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.
Experimental: Bone Graft Sonic Toothbrush; 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; 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.
Experimental: Bone Graft Sonic and Dual-light Toothbrush; 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; 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.
Experimental: No surgery, Manual Toothbrush; 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; 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.
Experimental: No Surgery, Sonic Toothbrush; 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; 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.
Experimental: No Surgery, Sonic and Dual-light Toothbrush; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Stephen Yen, DMD, PhD, Children's Hospital Los Angeles and USC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Congenital Abnormalities; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Gingivitis; Cleft Lip
• Other Study ID Numbers: CHLA-23-00184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes