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NCT Number: NCT06122805

Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in 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.

Recruiting

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Key information

Conditions

Toothbrushing Cleft Lip Cleft Lip and Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gingival Diseases Gingivitis Infections Lip Diseases Mouth Abnormalities Mouth Diseases Periodontal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Toothbrush

Device

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 outcomes

  1. Löe and Silness Gingival Index

    Time frame: 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.

  2. Bleeding index

    Time frame: 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 outcomes

  1. Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Polido, DDS

CONTACT

[email protected]

3233612130

Stephen Yen, DMD, PhD

CONTACT

[email protected]

3233612130

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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