Actively Recruiting

Phase Not Applicable
Age: 6Years - 20Years
All Genders
Healthy Volunteers
ID06122805

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

Led by Children's Hospital Los Angeles · Updated on 2024-05-13

198

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of different types of toothbrushes on the oral health of orthodontic patients with cleft lip and palate who are undergoing surgery. This study focuses on comparing periodontal health outcomes among patients receiving orthognathic surgery, bone graft surgery, or no surgery. It is a randomized clinical trial involving 189 patients to assess how well these toothbrushes manage gingivitis during the post-surgical period. The study tests three toothbrush types: a manual toothbrush, a sonic toothbrush, and a sonic toothbrush with a dual light feature. Patients are divided into groups based on their surgery type and the toothbrush used. The trial includes patients who are between 6 and 20 years old and are patients at a specialized orthodontic clinic. The study will analyze periodontal health using various indices such as the Plaque Index, Gingival Index, Bleeding on Probing, and Periodontal Probing Depth over 18 weeks with evaluations every six weeks. Participants will be monitored at several time points for periodontal outcomes including gingival inflammation and bleeding. The study collects data through clinical assessments scoring plaque and gingival health. Researchers will also track bleeding and probing depths to measure the effectiveness of each toothbrush type. The total observation period is 18 weeks, during which participants' oral health will be closely assessed and compared across the different treatment groups.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 20Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Physical inability to brush teeth
  • Cognitive inability to comprehend and follow directions

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 18 weeks

Participants use one of three types of toothbrushes: manual, sonic, or sonic with dual light therapy. This occurs across groups with and without oral surgery.

Visits every 6 weeks for evaluations

Trial Site Locations

Total: 1 location

1

Chilldren's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

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Research Team

S

Stephen Yen, DMD, PhD

J

Jose Polido, DDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

9

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Published Research Related To This Trial

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.

Renzo A Ccahuana-Vasquez, Erinn Conde, Julie M Grender...

https://pubmed.ncbi.nlm.nih.gov/26665291