Change in Biting Force After Botox Injection

NCT ID: NCT04940104

Last Updated: 2021-06-25

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-01

Brief Summary

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Implant rehabilitation is a successful treatment option for edentulous patients. Decreasing bone loss around implants is an important target for all implantologists. It has been shown that pathological forces, such as bruxism, may in fact result in bone loss and eventual implant failure.

Botilinium Toxin is a material of many clinical uses. Beside its cosmetic applications, it has been used in the treatment of masseter muscle hypertrophy.

Purpose: To investigate the effect of botilinium toxin injection on biting forces, and its ultimate effect on peri-implant bone changes.

Detailed Description

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Conditions

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Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Botox

Group Type EXPERIMENTAL

Botox Injectable Product

Intervention Type DRUG

Botox is a well known neurotoxin that is derived from the bacterium clostridium botulinium. Its therapeutic applications are variable and well documented, alongside its cosmetic applications. There are seven known serotypes of Botox, from A to G, but only two types; A \&B, are available for medical and cosmetic uses.

Control No Botox

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Botox Injectable Product

Botox is a well known neurotoxin that is derived from the bacterium clostridium botulinium. Its therapeutic applications are variable and well documented, alongside its cosmetic applications. There are seven known serotypes of Botox, from A to G, but only two types; A \&B, are available for medical and cosmetic uses.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a partially edentulous mandible, Kennedy Class I configuration, who are indicated for rehabilitation with partial implant overdenture prostheses, and who complained of Bruxism.

Exclusion Criteria

* The presence of notable facial asymmetry.
* Severe malocclusion
* Pregnancy
* A history of any serious medical illness
* Drug allergy.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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British University In Egypt

OTHER

Sponsor Role lead

Responsible Party

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Sara Fikry El Shafei

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The British University in EGYPT

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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21-009

Identifier Type: -

Identifier Source: org_study_id

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