NCT04366869

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: October University for Modern Sciences and Arts · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bruxism

Interventions

Type	Name	Description
DEVICE	overdenture	removal of overdenture at night
DEVICE	occlusal splint	occlusal splint on overdenture
DRUG	Botox	Botox injection i masseter in temporalis

Timeline

• Start date: 2019-07-07
• Primary completion: 2020-07-07
• Completion: 2020-08-01
• First posted: 2020-04-29
• Last updated: 2020-12-17

Locations

1 site across 1 country: Egypt