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Change in Biting Force After Botox Injection

Primary Purpose

Bruxism

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Botox Injectable Product
Sponsored by
British University In Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bruxism

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • The British University in EGYPT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Botox

Control No Botox

Arm Description

Outcomes

Primary Outcome Measures

Change in biting force
Biting force measured using T-Scan

Secondary Outcome Measures

Bone changes around implant
Bone changes using 3D CBCT

Full Information

First Posted
June 18, 2021
Last Updated
June 18, 2021
Sponsor
British University In Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04940104
Brief Title
Change in Biting Force After Botox Injection
Official Title
Change in Biting Force After Botilinium Toxin Injection and Its Effect on Peri Implant Bone Changes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British University In Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox
Arm Type
Experimental
Arm Title
Control No Botox
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Botox Injectable Product
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in biting force
Description
Biting force measured using T-Scan
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Bone changes around implant
Description
Bone changes using 3D CBCT
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
The British University in EGYPT
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Change in Biting Force After Botox Injection

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