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Clinical Trial 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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04366869
Study type Interventional
Source October University for Modern Sciences and Arts
Contact
Status Completed
Phase N/A
Start date July 7, 2019
Completion date August 1, 2020

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