Skip to main content
OpenTrials
Completed

NCT Number: NCT04940104

Change in Biting Force After Botox Injection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bruxism Behavior Habits Stomatognathic Diseases Tooth Diseases

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The British University in EGYPT

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botox Injectable Product

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.

Primary outcomes

  1. Change in biting force

    Time frame: 12 months

    Biting force measured using T-Scan

Secondary outcomes

  1. Bone changes around implant

    Time frame: 12 months

    Bone changes using 3D CBCT

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 25, 2021
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.