Which is More Effective in Management of Bruxism: Botox or Occlusal Splints

Study Overview
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Brief Summary
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The aim of this study is to compare the efficacy of Botulinum toxin (Botox) and traditional occlusal splints for the management of bruxism in edentulous patients rehabilitated with MIOD

Detailed Description
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42 edentulous patients having implant retained mandibular overdenture suffering from bruxism with clinical manifestation, will be randomly divided into three groups, group 1 control group (traditional approach of removing denture at night) ,group 2 will be managed by occlusal splints whereas group 3 will be managed with botulinum toxin injection (Botox). New maxillary dentures and mandibular over dentures will be constructed for both groups. Muscle activity will be measured at time of denture insertion (T0), 3(T3) 6(T6), 9(T9) and 12(T12) month of treatment. Patients satisfaction will be evaluated at the time of denture insertion (T0), 6(T6), and 12(T12) month of treatment using TMD/ NS numeric scales 10 cm questionnaire which include: headache, face pain, face tension, limitation of mouth opening and complaints during mastication.

Official Title
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Which is More Effective in Management of Bruxism for Implant Overdenture Patients: Botox or Occlusal Splints - A One Year Clinical Study

Conditions
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Bruxism

Intervention / Treatment
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* Device: overdenture
* Device: occlusal splint
* Drug: Botox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed with bruxism patients had mandibular implant retained overdentures within the previous 3 years cooperative patients physically and psychologically able patients to tolerate the procedure Exclusion Criteria: patients taking muscle relaxants patients without neuromuscular control poor oral hygiene

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>traditional approach of removing denture at night | Device: overdenture<br>* removal of overdenture at night<br>|
| Experimental: intervention 1<br>occlusal splint | Device: occlusal splint<br>* occlusal splint on overdenture<br>|
| Experimental: intervention 2<br>Botox | Drug: Botox<br>* Botox injection i masseter in temporalis<br>* Other names: Bolitinum Toxins;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction: questionnaire | Patients satisfaction was evaluated using TMD/ NS numeric scales 10 cm questionnaire which included: headache, face pain, face tension, limitation of mouth opening and complaints during mastication with scores from 1 to 10 whereas 1 means least pain and 10 means highest pain.it was assessed at baseline (T0), then after 3months(T3) then after 6months from baseline(T6), then after 9months from baseline(T9) and finally after 12 months from baseline (T12). which means every 3 months. | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography | measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months | 12 months |