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

Primary Purpose

Bruxism

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

overdenture

occlusal splint

Botox

About this trial

This is an interventional treatment trial for Bruxism

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

control

intervention 1

intervention 2

Arm Description

traditional approach of removing denture at night

occlusal splint

Botox

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Electromyography

measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months

Full Information

NCT ID

NCT04366869

First Posted

April 21, 2020

Last Updated

December 15, 2020

Sponsor

October University for Modern Sciences and Arts

1. Study Identification

Unique Protocol Identification Number

NCT04366869

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

July 7, 2019 (Actual)

Primary Completion Date

July 7, 2020 (Actual)

Study Completion Date

August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

October University for Modern Sciences and Arts

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bruxism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

Active Comparator

Arm Description

traditional approach of removing denture at night

Arm Title

intervention 1

Arm Type

Experimental

Arm Description

occlusal splint

Arm Title

intervention 2

Arm Type

Experimental

Arm Description

Botox

Intervention Type

Device

Intervention Name(s)

overdenture

Intervention Description

removal of overdenture at night

Intervention Type

Device

Intervention Name(s)

occlusal splint

Intervention Description

occlusal splint on overdenture

Intervention Type

Drug

Intervention Name(s)

Botox

Other Intervention Name(s)

Bolitinum Toxins

Intervention Description

Botox injection i masseter in temporalis

Primary Outcome Measure Information:

Title

Patient satisfaction: questionnaire

Description

Time Frame

12months

Secondary Outcome Measure Information:

Title

Electromyography

Description

measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina Elawady, PHD

Organizational Affiliation

Lecturer

Official's Role

Principal Investigator

Facility Information:

Facility Name

MSA

City

Giza

ZIP/Postal Code

311

Country

Egypt

12. IPD Sharing Statement

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

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