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

Sponsor

Children's Hospital Los Angeles (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06122805

Collaborator

(none)

198

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Toothbrushing Gingivitis Cleft Lip and Palate	Device: Toothbrush	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RandomizedRandomized

Masking:

Single (Investigator)

Masking Description:

randomized assignment of study ID number

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chilldren's Hospital Los Angeles	Los Angeles	California	United States	90027

Sponsors and Collaborators

Children's Hospital Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Stephen Yen, Associate Professor, Children's Hospital Los Angeles

ClinicalTrials.gov Identifier:

NCT06122805

Other Study ID Numbers:

CHLA-23-00184

First Posted:

Nov 8, 2023

Last Update Posted:

Nov 8, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Gingivitis

Cleft Lip

Study Results

No Results Posted as of Nov 8, 2023