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Effect of Botulinum Toxin-A on Free Gingival Graft

NCT05822323 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-04-20

No results posted yet for this study

Summary

The aim of this study was to examine the effects of Botulinum Toxin-A (BTX-A) injection to the mental muscle on the free gingival graft (FGG) operation. Forty patients with Miller class III gingival recession and keratinized gingival insufficiency in their lower 1st incisors were divided into 2 groups as FGG operation (n=20) and 5 unit (U) BTX-A injection into the mental muscle immediately after FGG operation (n=20). Periodontal parameters (plaque index (PI), gingival index (GI), probing pocket depth (PPD), keratinized gingival amount (KGA), attached gingival amount (AGA)) were measured from the lower 1st incisors at the beginning and at the 1st, 3rd and 6th months after the operation, clinical attachment level (CAL), gingival thickness (GT), gingival recession amount (GRA), gingival recession width (GRW) and root closure percentage (RCP (%)) were evaluated. There was no statistically significant difference in terms of PI and GI levels (p\>0.05). The PPD levels of the study group at the postoperative 3rd month was found to be statistically significantly lower than the control group (p\<0.05). While the change in GT and RCP (%) levels were found to be statistically significantly higher than the control group, the change in GRW and CAL levels were statistically significantly lower (p\<0.05). According to the results of this study, it can be stated that BTX-A injection applied to the mental muscle after FGG operation may have positive effects in terms of KGA, AGA, GT, RCP (%), GRW and CAL parameters.

Conditions

  • Gingival Recession, Localized

Interventions

OTHER

BTX-A

Vials of 100 U Allergan Botox® (Allergan, Inc., Irvine, California) were diluted with 2 ml of physiological saline and made ready for use. The midline was determined at the mentum region. 5 U of BTX-A was injected into the mental muscle approximately 1 cm away from the chin tip and the midline

PROCEDURE

free gingival graft

The mandibular first incisor was treated with FGG operation due to Miller class III gingival recession and insufficient amount of keratinized gingiva.

Sponsors & Collaborators

  • Kevser Sokmen

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-10-01
Completion
2021-10-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822323 on ClinicalTrials.gov