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
About this trial
This is an interventional supportive care trial for Bruxism
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.
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
NCT ID
NCT04940104
First Posted
June 18, 2021
Last Updated
June 18, 2021
Sponsor
British University In Egypt
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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