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Recruiting NCT06122805

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

No phase Interventional Toothbrushing Gingivitis Cleft Lip and Palate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Toothbrush.
Who it may be relevant to
Registry conditions: Toothbrushing, Gingivitis, Cleft Lip and Palate. Basic parameters: 6 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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

  • 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.

Primary outcome measures

  • Löe and Silness Gingival Index [Time frame: 18 weeks, 6 weeks apart evaluations]
  • Bleeding index [Time frame: 18 weeks, 6 weeks apart evaluations]
Secondary outcome measures (1)
  • Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient [Time frame: 18 weeks, 6 week apart evaluations]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Chilldren's Hospital Los Angeles — Los Angeles

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. PMID 26665291

Identifiers

NCT: NCT06122805 · CHLA-23-00184

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗