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

Last updated: May 9, 2024
Sponsor: Children's Hospital Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Toothbrush

Clinical Study ID

NCT06122805
CHLA-23-00184
  • Ages 6-20
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient of record of the Craniofacial and Special Care Orthodontic Clinic atChildren'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 orunilateral cleft lip and palate

Exclusion

Exclusion Criteria:

  • physical inability to brush teeth

  • cognitive inability to comprehend and follow directions.

Study Design

Total Participants: 198
Treatment Group(s): 1
Primary Treatment: Toothbrush
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
November 30, 2027

Study 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.

Connect with a study center

  • Chilldren's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

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