Health TrialsbyHealthPanel

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

ConditionsToothbrushingGingivitisCleft Lip and Palate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-20
SponsorChildren's Hospital Los Angeles

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

physical inability to brush teeth

cognitive inability to comprehend and follow directions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

198 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Orthognathic Surgery Manual ToothbrushExperimental treatment 1 intervention
Group B: Orthognathic Surgery Sonic toothbrushExperimental treatment 1 intervention
Group C: Orthognathic Surgery Sonic and dual light toothbrushExperimental treatment 1 intervention
Group D: Bone Graft Manual ToothbrushExperimental treatment 1 intervention
Group E: Bone Graft Sonic ToothbrushExperimental treatment 1 intervention
Group F: Bone Graft Sonic and Dual-light ToothbrushExperimental treatment 1 intervention
Group G: No surgery, Manual ToothbrushExperimental treatment 1 intervention
Group H: No Surgery, Sonic ToothbrushExperimental treatment 1 intervention
Group I: No Surgery, Sonic and Dual-light ToothbrushExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Löe and Silness Gingival Index

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.

Time frame
18 weeks, 6 weeks apart evaluations
2

Bleeding index

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

Time frame
18 weeks, 6 weeks apart evaluations

Secondary outcomes

1

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

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.

Time frame
18 weeks, 6 week apart evaluations

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Los Angeles

Lead sponsor

Source ClinicalTrials.gov
Apply now