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CompletedNCT04940104Updated Jun 25, 2021

Change in Biting Force After Botox Injection

An interventional study of Botox Injectable Product in Bruxism, sponsored by British University In Egypt. Completed at 1 site in Egypt. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-25.

Sponsored by British University In Egypt · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jan 2019, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Bruxism

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03

In context

Bruxism

166 studies on the registry are indexed under Bruxism; 38 are open to participants now.

This study's enrollment of 20 is below the median of 38 across 103 interventional studies indexed under Bruxism.

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Lead sponsor

British University In Egypt is the lead sponsor of 67 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • The presence of notable facial asymmetry.
  • Severe malocclusion
  • Pregnancy
  • A history of any serious medical illness
  • Drug allergy.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Botox

    Drug: Botox Injectable Product

  • No intervention
    Control No Botox

Interventions

  • DrugBotox 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.

06

What researchers measure

Primary outcomes

  1. Change in biting force

    Biting force measured using T-Scan

    Time frame: 12 months

Secondary outcomes

  1. Bone changes around implant

    Bone changes using 3D CBCT

    Time frame: 12 months

07

Study locations

1 site
  • The British University in EGYPT
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04940104
Lead sponsor
British University In Egypt
Responsible party
Sara Fikry El Shafei (Principle Investigator, British University In Egypt) — Principal investigator
First posted
Jun 25, 2021
Start date
Jan 1, 2019
Primary completion
Jun 1, 2019
Completion
Dec 1, 2020
Last update
Jun 25, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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