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

Not Applicable

Completed

• Conditions: Bruxism
• Interventions: Device: overdenture; Device: occlusal splint; Drug: Botox

• Registration Number: NCT04366869
• Lead Sponsor: October University for Modern Sciences and Arts

Brief Summary

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

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 Timeline

• Study Start: 2019-07-07
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-29
• Primary Completion: 2020-07-07
• Study Completion: 2020-08-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	overdenture	traditional approach of removing denture at night
intervention 1	occlusal splint	occlusal splint
intervention 2	Botox	Botox

Primary Outcome Measures

Name	Time	Method
Patient satisfaction: questionnaire	12months	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.

Secondary Outcome Measures

Name	Time	Method
Electromyography	12 months	measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months

Trial Locations

Locations (1)

MSA; 🇪🇬 Giza, Egypt