Evaluating the effects of clear aligners on bruxism symptoms
Analysis of Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism: Single-centre Interventional Case-control With Device
This study is testing if clear aligners can help reduce teeth grinding and muscle tension in people with bruxism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06343194 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of clear aligners in treating symptoms associated with bruxism, including masseter muscle hypertrophy and teeth grinding. It will utilize the Bruxoff® device to monitor the electromyographic activity of the masseter muscles during sleep before and after the initiation of clear aligner therapy. The study will compare outcomes between patients diagnosed with bruxism and those without the condition to determine the impact of the treatment. The findings will provide insights into the efficacy of clear aligners in managing bruxism-related issues.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with sleep bruxism who are willing to undergo treatment with clear aligners.
Not a fit: Patients with significant temporomandibular joint disorders or those undergoing other orthodontic therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from bruxism.
How similar studies have performed: While there is limited data on the specific use of clear aligners for bruxism, similar approaches in managing dental conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acceptance of the treatment plan with clear aligners; * Acceptance of informed consent to the study; * Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine. * Subjects who don't meet the criteria of sleep bruxism by American Academy of Sleeping Medicine in good health. Exclusion Criteria: * Patients with morphological and structural alterations to the temporomandibular joint, e.g. Condillary hypertrophy; * Medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia; * Patients in therapy with myorelaxants or other medicines that affect chewing muscle activity; * Patients with pacemakers; * Patients with periodontal diseases; * Patients with ongoing orthodontic therapy or with prosthetic rehabilitation
Where this trial is running
Rome, Lazio
- UOC Odontoiatria Generale e Ortodonzia, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore — Rome, Lazio, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Cordaro, professor — UOC Odontoiatria Generale e Ortodonzia
- Study coordinator: Massimo Cordaro, professor
- Email: massimo.cordaro@unicatt.it
- Phone: +39 0630154286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.