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

Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366869
• Other study ID #: OctoberUMSA
• Status: Completed
• Phase: N/A
• Start date: July 7, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: December 2020
• Source: October University for Modern Sciences and Arts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 1, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism

Intervention

Device:
• overdenture
removal of overdenture at night
• occlusal splint
occlusal splint on overdenture

Drug:
• Botox
Botox injection i masseter in temporalis

Locations

Country	Name	City	State
Egypt	MSA	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October University for Modern Sciences and Arts

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12months
Secondary	Electromyography	measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months	12 months