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

October University for Modern Sciences and Arts

Status: Completed

Conditions: Bruxism

Treatments: Drug: Botox; Device: overdenture; Device: occlusal splint

Study type: Interventional

Funder types: Other

Identifiers

NCT04366869

OctoberUMSA

Details and patient eligibility

About

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

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 3 patient groups

control

Active Comparator group

Description:

traditional approach of removing denture at night

Treatment:

Device: overdenture

intervention 1

Experimental group

Description:

occlusal splint

Treatment:

Device: occlusal splint

intervention 2

Experimental group

Description:

Botox

Treatment:

Drug: Botox