Comparative Analysis of Botox, Occlusal Splints and Traditional Management of Bruxism in Patients With Implant Overdenture: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Retention
Study Overview
Brief Summary
Objective To compare the effects of botulinum toxin type A (BTX-A) injections, occlusal stabilization splint therapy, and nocturnal overdenture removal on masticatory muscle activity and overdenture retention in patients with sleep bruxism wearing implant-retained mandibular overdentures.
Methods This randomized, single-blind, parallel-group clinical trial allocated patients with definite sleep bruxism to one of three groups (1:1:1): BTX-A injections with nocturnal overdenture wear, occlusal stabilization splint therapy with nocturnal overdenture wear, or nocturnal overdenture removal (control). Electromyographic (EMG) activity of the masseter and temporalis muscles was assessed at baseline and at 3, 6, 9, and 12 months. Overdenture retention was measured at 1, 3, 6, and 12 months using a digital force gauge. Intergroup comparisons were performed using one-way ANOVA with Tukey's post hoc test, and intragroup comparisons using repeated-measures ANOVA (α = 0.05).
Detailed Description
Diagnosis of sleep bruxism Electromyography (EMG) is a valuable tool for diagnosing sleep bruxism (SB), as it records electrical activity in the masticatory muscles (e.g., masseter and temporalis) during sleep, providing objective data on the frequency, duration, and intensity of muscle contractions. Unlike subjective patient reports or clinical examinations, EMG can detect SB episodes even when patients are unaware of their bruxism, which occurs in up to 80% of cases. While polysomnography (PSG) remains the gold standard for SB diagnosis due to its comprehensive monitoring of brain activity, muscle movements, and other physiological parameters, ambulatory EMG offers a more practical and accessible alternative for clinical settings. Despite this, EMG is widely used in research and clinical practice, particularly when combined with patient history and clinical examination, to achieve a reliable SB diagnosis conducted the assessments to minimize measurement bias.
Prosthetic Protocol
All participants received newly fabricated ODs to replace existing prostheses with compromised artificial dentition. The prosthetic rehabilitation included:
- Installation of medium-retention nylon caps within metal housings to ensure consistent retention parameters
- Restoration of opposing partially edentulous arches with fixed partial dentures
- A one-month adaptation period incorporating necessary occlusal adjustments and prosthetic modifications Intervention Protocols Throughout the study duration, distinct wearing protocols were implemented for each experimental group: Groups I and II maintained continuous OD wear during sleep. Group I received BTX-A injection; Group II received additional intervention through conventional maxillary occlusal stabilization splints and Group III (Control Group) participants were instructed to remove their overdentures (ODs) during nocturnal sleep periods.
Group I protocol:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •a confirmed diagnosis of definite sleep bruxism (SB)
- •retention of natural dentition in the maxillary dental arch, without missing a single tooth of 6 anterior teeth, with no more than one or two missing premolar or molar teeth per quadrant
- •existing implant-retained single overdentures (OD) that had been functionally loaded for at least one year prior to study initiation
Exclusion Criteria
- •had undergone any previous therapeutic interventions for bruxism
- •exhibited medical conditions with known impacts on temporomandibular joint (TMJ) function, including (but not restricted to) post-radiation effects, osteoarthritis, or trauma-related pathologies.
- •Any contraindication for BTX-A injection such as, allergy, pregnancy, and lactation.
Arms & Interventions
Botox injection
Botox Administration Botulinum toxin type A (BTX-A; Botox, Allergan, Inc., Irvine, CA, USA) was administered through intramuscular injection into the masseter and temporalis muscles during a single treatment session. The masseter muscle received 30 units of BTX-A, while the temporalis muscle received 25 units. All injections were guided by electromyography
Intervention: Botulinium toxin type A injection (Drug)
Maxillary Occlusal Stabilization Splint
A maxillary full-arch hard clear acrylic muscle stabilization splint was fabricated for each participant. Each splint underwent intraoral evaluation to ensure optimal fit, retention, and stability on the maxillary dentition.
Intervention: Maxillary Occlusal Stabilization Splint (Device)
Removal of overdenture
Overdentures were removed at night
Outcomes
Primary Outcomes
Retention
Time Frame: 1month, 3 months, 6 months, 12 months
For all groups, retention of the implant-supported overdenture was measured using a digital force gauge device
Secondary Outcomes
- II. Electromyography(1 months, 3 months, 6 months, 12 months)
Investigators
Wafaa Ibrahim
Associate Professor
Delta University for Science and Technology