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

NCT06842290 | Not Yet Recruiting

• 1 other identifier: PER3,3,2
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Keratinized tissue width

  Measured at baseline ,3months ,6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

ACTIVE COMPARATOR

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

Procedure: Coronally advanced flap

Interventions

Botulinum toxin-A injection PROCEDURE

Botulinum toxin-A Injection Mentalis muscle in lower anterior teeth

Intervention arm

Coronally advanced flap PROCEDURE

Coronally Advanced Flap andDe-epithelized Free Gingival Graft

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Gingival Recession

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02