Change in Biting Force After Botox Injection

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

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.

Study Overview

• Status: Completed
• Conditions: Bruxism
• Intervention / Treatment: Drug: Botox Injectable Product

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • The British university in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botox	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.
No Intervention: Control No Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biting force	Biting force measured using T-Scan	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone changes around implant	Bone changes using 3D CBCT	12 months

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Bruxism
• Other Study ID Numbers: 21-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No