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

NCT ID: NCT04366869

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-07

Study Completion Date

2020-08-01

Brief Summary

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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

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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

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Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

traditional approach of removing denture at night

Group Type ACTIVE_COMPARATOR

overdenture

Intervention Type DEVICE

removal of overdenture at night

intervention 1

occlusal splint

Group Type EXPERIMENTAL

occlusal splint

Intervention Type DEVICE

occlusal splint on overdenture

intervention 2

Botox

Group Type EXPERIMENTAL

Botox

Intervention Type DRUG

Botox injection i masseter in temporalis

Interventions

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overdenture

removal of overdenture at night

Intervention Type DEVICE

occlusal splint

occlusal splint on overdenture

Intervention Type DEVICE

Botox

Botox injection i masseter in temporalis

Intervention Type DRUG

Other Intervention Names

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Bolitinum Toxins

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Dina ElAwady

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Elawady, PHD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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MSA

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OctoberUMSA

Identifier Type: -

Identifier Source: org_study_id