NCT04940104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

June 18, 2021

Last Update Submit

June 18, 2021

Conditions

Bruxism

Outcome Measures

Primary Outcomes (1)

  • Change in biting force

    Biting force measured using T-Scan

    12 months

Secondary Outcomes (1)

  • Bone changes around implant

    12 months

Study Arms (2)

Botox

EXPERIMENTAL
Drug: Botox Injectable Product

Control No Botox

NO INTERVENTION

Interventions

Botox Injectable ProductDRUG

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.

Botox

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British University in EGYPT

Cairo, Egypt

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 25, 2021

Study Start

January 1, 2019

Primary Completion

June 1, 2019

Study Completion

December 1, 2020

Last Updated

June 25, 2021

Record last verified: 2021-06

Locations

EG(1)