Comparative Analysis of Botox, Occlusal Splints and Traditional Management of Bruxism in Patients With Implant Overdenture: A Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: 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.
干预措施: Maxillary Occlusal Stabilization Splint (Device)
Removal of overdenture
Overdentures were removed at night
结局指标
主要结局
Retention
时间窗: 1month, 3 months, 6 months, 12 months
For all groups, retention of the implant-supported overdenture was measured using a digital force gauge device
次要结局
- II. Electromyography(1 months, 3 months, 6 months, 12 months)
研究者
Wafaa Ibrahim
Associate Professor
Delta University for Science and Technology