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

October University for Modern Sciences and Arts42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bruxism

Interventions

overdentureDEVICE

removal of overdenture at night

occlusal splintDEVICE

occlusal splint on overdenture

BotoxDRUG

Botox injection i masseter in temporalis

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

MSA

Giza, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 12months

Secondary Outcomes

Electromyography

measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months

Time frame: 12 months

Data from ClinicalTrials.gov

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