A Comparative Study Between Botulinum Toxin Versus Platelet Rich Fibrin Injection for Treatment of Temporomandibular Joint Internal Derangement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Score (Visual Analogue Scale, VAS)
研究概览
简要总结
Temporomandibular joint (TMJ) internal derangement is a common cause of temporomandibular disorders and is often associated with pain, restricted mandibular movement, joint sounds, and functional limitations during mastication and mouth opening. Various treatment modalities have been proposed to manage these symptoms, aiming to reduce pain and improve joint function.
This randomized clinical study was conducted to compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) in the management of TMJ internal derangement. A total of 20 patients diagnosed with TMJ internal derangement were randomly allocated into two equal groups. Group I received intracapsular I-PRF injections into the superior joint space of the temporomandibular joint, while group II received botulinum toxin injections into the lateral pterygoid muscle.
Clinical evaluation was performed using subjective and objective parameters at one, three, and six months following treatment. Outcomes included assessment of pain, maximum mouth opening, mandibular movements, joint tenderness, and muscle tenderness upon palpation. Radiographic evaluation was conducted using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following the interventions.
The study aimed to determine which treatment modality provided superior clinical and radiographic outcomes for the management of TMJ internal derangement.
详细描述
Temporomandibular joint (TMJ) internal derangement represents a common cause of temporomandibular disorders (TMDs) and is frequently associated with pain and functional limitations. Patients affected by TMJ internal derangement commonly present with pain during mastication, difficulty or pain during mouth opening, joint sounds such as clicking or crepitation, and preauricular pain. Due to the multifactorial nature of this condition, numerous treatment modalities have been investigated to achieve effective symptom relief and functional improvement.
The aim of this clinical study was to evaluate and compare the effectiveness of botulinum toxin type A (BOTOX) injection into the lateral pterygoid muscle versus intracapsular injection of injectable platelet-rich fibrin (I-PRF) for the management of TMJ internal derangement.
This randomized clinical study was conducted on a total of 20 patients diagnosed with TMJ internal derangement. The participants were randomly and equally allocated into two groups using an online randomization tool (www.randomizer.org). Group I consisted of 10 patients who received intracapsular injections of injectable platelet-rich fibrin (I-PRF) into the superior joint space of the temporomandibular joint. Group II consisted of 10 patients who received botulinum toxin type A injections into the lateral pterygoid muscle.
Patients in both groups were evaluated using both subjective and objective parameters at baseline and during follow-up periods at one month, three months, and six months following injection. Clinical evaluation included assessment of pain, maximum mouth opening, and mandibular movements in all directions to determine improvement in mouth mobility. Tenderness was assessed by palpation of the masticatory muscles, including the temporalis, masseter, and lateral pterygoid muscles, as well as palpation of the temporomandibular joint through the external auditory canal.
Radiographic evaluation was performed using magnetic resonance imaging (MRI) to assess intra-articular changes of the temporomandibular joint following treatment. MRI findings were used to evaluate joint structure, disc position, and overall intra-articular condition after the intervention.
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
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 15 to 50 years.
- •Adults of both genders.
- •Patients free from systemic disease (ASA I).
- •Patients presenting with persistent symptoms and signs of temporomandibular disorders, specifically anterior disc displacement with reduction (ADDwR).
- •Patients willing to comply with the follow-up schedule and treatment protocol.
排除标准
- •Pregnant or lactating women, or women with osteoporosis.
- •Patients who have had previous TMJ surgery.
- •Patients who have undergone previous arthrocentesis.
- •Any other temporomandibular joint disease that may confound diagnosis (e.g., myofascial pain-dysfunction syndrome, MPDS).
- •Patients allergic to components of the injection solutions.
- •Patients with previous trauma to the TMJ.
- •Patients with metal bullets in the body, metallic foreign body in the eye, or intracranial aneurysm clips (unless made of titanium).
- •Patients using anticoagulant or immunosuppressive medications.
研究组 & 干预措施
I-PRF Injection Group (Group I)
This arm included 10 patients who underwent arthrocentesis of the temporomandibular joint, followed by 1 mL of intra-articular injectable platelet-rich fibrin (I-PRF).
干预措施: Injectable Platelet-Rich Fibrin (I-PRF) Injection (Procedure)
Botulinum Toxin Injection Group (Group II)
This arm included 10 patients who received an ultrasound-guided injection of 7 mL containing 35 units of botulinum toxin type A (BOTOX) into the lateral pterygoid muscle.
干预措施: Botulinum Toxin Type A (BOTOX) Injection (Drug)
结局指标
主要结局
Pain Score (Visual Analogue Scale, VAS)
时间窗: 1 month, 3 months, and 6 months post-injection
Pain associated with temporomandibular joint internal derangement was assessed using a 10-point visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst pain. Pain was measured at baseline (pre-injection) and at follow-up visits. Comparisons were made within each group over time and between the I-PRF and BOTOX groups to determine the relative effectiveness of each treatment in reducing TMJ pain.
Joint Sounds (Clicking) Assessment
时间窗: 1 month, 3 months, and 6 months post-injection
The presence or absence of TMJ clicking was assessed by bimanual palpation during mouth opening and closing. Changes over time were recorded within groups and between the I-PRF and BOTOX groups.
MRI Assessment of Disc Position
时间窗: Baseline, 1 month, 3 months, and 6 months post-injection
MRI was performed to evaluate the position and structure of the TMJ articular disc. Disc positions were categorized as Superior (Normal), Reducing Disc Displacement (RDD), or Non-Reducing Disc Displacement (NRDD). Changes were compared within each group over time and between groups.
次要结局
- Maximal Mouth Opening (MMO)(1 month, 3 months, and 6 months post-injection)
- Lateral Mandibular Movements (Right and Left)(1 month, 3 months, and 6 months post-injection)
- Protrusive Mandibular Movement (PM)(1 month, 3 months, and 6 months post-injection)