Change in Biting Force After Botox Injection

Bruxism Clinical Trial

Official title:

Change in Biting Force After Botilinium Toxin Injection and Its Effect on Peri Implant Bone Changes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940104
• Other study ID #: 21-009
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2021
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	The British University in EGYPT	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biting force	Biting force measured using T-Scan	12 months
Secondary	Bone changes around implant	Bone changes using 3D CBCT	12 months