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

December 15, 2020 updated by: Dina ElAwady, October University for Modern Sciences and Arts

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 311
        • MSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
traditional approach of removing denture at night
Device: overdenture
removal of overdenture at night
Experimental: intervention 1
occlusal splint
Device: occlusal splint
occlusal splint on overdenture
Experimental: intervention 2
Botox
Drug: Botox
Botox injection i masseter in temporalis
Other Names:
  • Bolitinum Toxins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction: questionnaire
Time Frame: 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.
12months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography
Time Frame: 12 months
measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October University for Modern Sciences and Arts

Investigators

  • Principal Investigator: Dina Elawady, PHD, Lecturer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2019

Primary Completion (Actual)

July 7, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OctoberUMSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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