Effect of Botulinum Toxin a Injection in Treatment of Recession RT1 and RT2

February 23, 2025 updated by: Mayar Mostafa Tawfik Ali, Cairo University

Effect of Botulinum Toxin -A Injection in Mentalis Muscle with Coronally Advanced Flap and De-epithelized Free Gingival Graft in Treatment of RT1 , RT2 Gingival Recession _Randomized Control Trial

The goal of this study type: clinical trial] is to learn the effect of Botulinum Toxin _A injection in treatment of RT1andRT2 Gingival recession in lower anterior teeth .

Primary outcome is keratinzed tissue width. Researchers will compare Coronally Advanced flap with De-epithelized free gingival graft and Botulinum toxin-A injection in Mentalis muscle with coronally advanced flap with De-epithelized free gingival graft alone .

The outcome will be measured at baseline, after 3 months and after 6 mobths _medical history

  • 3 mm horizontal incisions, then two vertical incisions
  • deepitheliztion of anatomical papillae
  • superficial and deep incisions
  • harvesting DFGG
  • Suturing
  • BOTOX injection

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Single or multiple RT1, RT2 GR patient
  • patients ≥18 years
  • systemically healthy, full mouth plaque score, full mouth bleeding score ≤ 15% after phase I therapy
  • clinical indication and/or patient request for recession coverage
  • well motivated patients, maintaining oral hygiene throughout study

Exclusion Criteria:

  • Pregnant or lactating women
  • Smokers' patients
  • Teeth with cervical restorations/abrasion.
  • Patients had a systemic condition affect blood components and healing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
In this arm principal investigator will preform coronally advanced flap with De-epithelized free gingival graft then will inject Botulinum toxin-A in Mentalis muscle after suturing
Procedure: Botulinum toxin-A injection
Botulinum toxin-A Injection Mentalis muscle in lower anterior teeth
Active Comparator: Control arm
In this arm no injection will be applied only coronally advanced flap with De-epithelized free gingival graft alone
Procedure: Coronally advanced flap
Coronally Advanced Flap andDe-epithelized Free Gingival Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Keratinized tissue width
Time Frame: Measured at baseline ,3months ,6 months
Measured at baseline ,3months ,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 4, 2025

Primary Completion (Estimated)

October 16, 2026

Study Completion (Estimated)

October 16, 2026

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PER3,3,2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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