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

NCT ID: NCT06842290

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2026-10-16

Brief Summary

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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

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Botulinum toxin-A injection

Intervention Type PROCEDURE

Botulinum toxin-A Injection Mentalis muscle in lower anterior teeth

Control arm

In this arm no injection will be applied only coronally advanced flap with De-epithelized free gingival graft alone

Group Type ACTIVE_COMPARATOR

Coronally advanced flap

Intervention Type PROCEDURE

Coronally Advanced Flap andDe-epithelized Free Gingival Graft

Interventions

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Botulinum toxin-A injection

Botulinum toxin-A Injection Mentalis muscle in lower anterior teeth

Intervention Type PROCEDURE

Coronally advanced flap

Coronally Advanced Flap andDe-epithelized Free Gingival Graft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mayar Mostafa Tawfik Ali

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PER3,3,2

Identifier Type: -

Identifier Source: org_study_id

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