Trial reportClinical oral investigations2020
Effect of treatment with a full-occlusion biofeedback splint on sleep bruxism and TMD pain: a randomized controlled clinical trial.
Trial report in Clinical oral investigations, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Pooled it
- Usefulness of biofeedback as a potentially educational treatment of temporomandibular disorders: a systematic review and network meta-analysis.BMC oral health · 2025Pooled it
- Comparative analysis of different types of occlusal splints for the management of sleep bruxism: a systematic review.BMC oral health · 2024Pooled it
- Impact of a Mindfulness-Based Intervention on Pain and Psychological Factors in Women With Chronic Painful Temporomandibular Disorders.Journal of oral rehabilitation · 2025Trial
- Recording the maxillomandibular relationship with the Aqualizer system prior to occlusal splint therapy for treating temporomandibular disorders: a randomized controlled trial.Scientific reports · 2023Trial
- Effects of vibratory feedback stimuli through an oral appliance on sleep bruxism: a 6-week intervention trial.Sleep & breathing = Schlaf & Atmung · 2022Trial
- Pain-Affective Disorder Comorbidity in the Temporomandibular Disorders: From Mechanistic Insights to Clinical Management.Neuroscience bulletin · 2026Review
- Comparison of digital splints versus traditional splints for bruxism management: a systematic review.BDJ open · 2026Review
- Diagnosis-based pathways for conservative and minimally invasive management of temporomandibular disorders: a scoping review.Journal of oral & facial pain and headache · 2026Article
- Behavioral Dentistry in the Digital Age: A Review of Biofeedback Occlusal Splint Therapy.Cureus · 2026Review
- Sleep Bruxism: A Narrative Review of Current Concepts, Mechanisms, and Clinical Implications.Journal of the Royal Society of New Zealand · 2026Review
- Management of Chronic Pain in Elderly Patients: The Central Role of Nurses in Multidisciplinary Care.Geriatrics (Basel, Switzerland) · 2025Review
- Understanding the clinical management of co-occurring sleep-related bruxism and obstructive sleep apnea in adults: A narrative and critical review.Journal of prosthodontics : official journal of the American College of Prosthodontists · 2025Review
- Temporomandibular disorders and mental health: shared etiologies and treatment approaches.The journal of headache and pain · 2025Review
- Assessment of pain location according to different types of bruxism.Journal of oral & facial pain and headache · 2025Article
- The Role of Occlusal Appliances in Reducing Masseter Electromyographic Activity in Bruxism.Journal of clinical medicine · 2024Article
- Patients' Satisfaction after the Treatment of Moderate Sleep Apnea and Nocturnal Bruxism with Botox or/and Thermoformed Occlusal Splints: A Pilot Study.Journal of personalized medicine · 2024Article
- Botulinum toxin for bruxism treatment: a nationwide study among oral and maxillofacial surgeons in Germany.Clinical oral investigations · 2024Article
- Effects of vibratory feedback stimuli through an oral appliance on sleep bruxism: A 14-week intervention trial.Journal of dental sciences · 2024Article
- Analysis of the Use of Sample Size and Effect Size Calculations in a Temporomandibular Disorders Randomised Controlled Trial-Short Narrative Review.Journal of personalized medicine · 2024Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe purpose of the present study was to analyze treatment outcome with a full-occlusion biofeedback (BFB) splint on sleep bruxism (SB) and TMD pain compared with treatment with an adjusted occlusal splint (AOS). MATERIALS AND
methodsForty-one patients were randomly allocated to a test (BFB) or a control (AOS) group and monitored over a 3-month period. Output variables were frequency and duration of bruxing events (bursts) and various pain symptoms.
resultsThe BFB group showed a statistically significant reduction in the frequency and duration of bursts and a statistically significant improvement in the patients' global well-being and the facial muscle pain parameter. After the treatment was stopped, the BFB group showed a statistically significant reduction in the average and maximum duration but no statistically significant change in the frequency of bursts.
conclusionsThe tested BFB splint is highly effective in reducing SB at the subconscious level, i.e., without waking the patient, and in achieving improvements in global pain perception. The results suggest that the BFB splint also provides a better treatment option for bruxism-related pain than an AOS. However, further research is needed, and specifically studies with a larger patient population displaying higher levels of pain at baseline. CLINICAL RELEVANCE: By reducing burst duration and therefore the pathological load on the masticatory apparatus, the BFB splint reduces TMD and bruxism-related symptoms and improves patients' physical well-being. In the long term, this could prevent damage to the TMJ. This study confirms the effectiveness and safety of this splint. THE UNIVERSAL TRIAL NUMBER: U1111-1239-2450 DRKS-ID REGISTRATION: DRKS00018092.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.