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NCT04722809: Botox
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
Phase 3 trial testing Botulinum toxin injection in Bruxism in 1 participant. Terminated before completion.
31 August 2022
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire Dijon |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 25 May 2022 |
| Primary completion | 31 August 2022 |
| Estimated completion | 31 August 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Botulinum toxin injection
- QOL-Brux
- Muscular strength of the jaw
- Intensity and frequency of episodes of nocturnal bruxism
- visual analogue pain scale
- Endobuccal and linea alba photographs
Conditions studied
- Bruxism — all drugs for Bruxism →
Sponsor
Centre Hospitalier Universitaire Dijon
Who can join
Adults 18 to 64, any sex, with Bruxism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bruxism is defined as a parafunction that consists of a clenching of the jaw and/or grinding of the teeth. It can occur when an individual is sleeping or awake or it can be mixed. Most often, it is primary or idiopathic bruxism, however when it is related to a cause it is qualified as secondary. Primary bruxism is a condition that is not well known to the general public, but I is very widespread (12% of the adult population). In addition, it can alter quality of life, as a result of associated sleep disorders, concentration disorders, daytime fatigue, chronic pain, etc. The current treatment for this condition is only symptomatic. Currently, one of the most effective treatments is the intramuscular injection of botulinum toxin A in the muscles of mastication. The progressive anticholinergic action results in a reduction of functional signs (dental pain, periodontal pain, temporomandibular joint pain, tension headaches, neck pain) and physical signs (reduction of the mass of the injected muscles, alba linea, tongue scalloping, limitation or stability of dental damage). However, these clinical data are practically not objectified in daily practice. Objective criteria would make it possible to measure the effectiveness of the treatment, to follow the patient, and to identify the early symptoms in order to prevent a recurrence. The aim of the prospective study is to concretely measure the strength and electromyographic activity of the muscles of mastication before and after botulinum toxin injection.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04722809
- Europe PMC full search
- ASCO Meeting Library
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04722809 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire Dijon
- Last refreshed: 26 August 2024
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