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Led by Children's Hospital Los Angeles · Updated on 2024-05-13
198
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery
S
Stephen Yen, DMD, PhD
J
Jose Polido, DDS
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Children's Hospital Los Angeles
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Dual‑light therapy sonic toothbrush | Sonic toothbrush | Manual toothbrush | Oscillating‑rotating powered toothbrush (current‑care reference) |
|---|---|---|---|---|
| What it is | A sonic toothbrush with built‑in dual‑light therapy combining sonic vibration and light emission tested after oral surgery | A standard sonic toothbrush tested in trial | A manual toothbrush arm included in trial | Oscillating‑rotating powered toothbrush is a commonly recommended option for plaque and gingivitis control in at‑home oral hygiene |
| Role in trial | Investigational device being evaluated | Active comparator toothbrush | Control comparator with manual brushing | External standard of care comparator not included in this study |
| Primary use | To assess gingival inflammation and plaque reduction in orthodontic surgical patients | Same purpose for comparison with investigational device | Baseline comparator for plaque and gingivitis measures | Used widely for daily plaque and gingivitis control in general population |
| How it is given or performed | Participants brush using the dual‑light sonic toothbrush during post‑surgical care | Participants brush with a sonic toothbrush | Participants brush with a manual toothbrush | Typically used by individuals at home according to manufacturer instructions |
| Evidence status | Effectiveness for gingivitis and plaque in surgical orthodontic patients is under investigation; results not yet established | Widely studied; shown to reduce plaque and gingivitis compared with manual brushing | Well established baseline instrument with known limitations in plaque control requiring user technique | Highest ranked for plaque and gingivitis reduction among toothbrush types |
| Important risks | Undetermined; surgical setting and combination light therapy may have unknown safety considerations | Minimal known risks similar to standard electric brushes | Low risk when used correctly | Generally safe when used as directed |
| Important limitations | No published efficacy or safety data yet; limited evidence available | Effectiveness depends heavily on brushing technique and consistency | Requires proper technique and may be less effective in complex surgical contexts | Availability and cost may be higher than manual options |
| Patient impact | Unknown; benefits not yet measured in this surgical context | Proven to improve gum health and reduce plaque more than manual brushing in general populations | Standard baseline with limited impact unless technique is optimal | Highest likelihood of reducing plaque and gingivitis among tested toothbrush types |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
9
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Renzo A Ccahuana-Vasquez, Erinn Conde, Julie M Grender...
https://pubmed.ncbi.nlm.nih.gov/26665291/Children's Hospital Los Angeles
Lead Sponsor
