Effect of Botulinum Toxin-A on Free Gingival Graft

NCT05822323 | Completed

• 1 other identifier: AlanyaAKÜ
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gingival recession; free gingival graft; mental muscle; Botulinum Toxin-A; keratinized gingiva

Outcome Measures

Primary Outcomes (33)

• Plaque İndex

  According to the plaque index (Silness\& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe. 1. There is plaque in the form of a film attached to the free gingival margin and adjacent tooth surface, which cannot be noticed with the naked eye, but can be seen with the help of a probe. 2. There is moderate plaque in the gingival pocket and on the tooth surface adjacent to the gingival margin, which can be seen with the naked eye. 3. There is dense plaque on the gingival pocket and the tooth surface adjacent to the gingival margin, the interdental area is completely filled with plaque.

  baseline plaque index

• Plaque İndex

  According to the plaque index (Silness\& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe. 1. There is plaque in the form of a film attached to the free gingival margin and adjacent tooth surface, which cannot be noticed with the naked eye, but can be seen with the help of a probe. 2. There is moderate plaque in the gingival pocket and on the tooth surface adjacent to the gingival margin, which can be seen with the naked eye. 3. There is dense plaque on the gingival pocket and the tooth surface adjacent to the gingival margin, the interdental area is completely filled with plaque.

  Change from plak index at 1 months

• Plaque İndex

  According to the plaque index (Silness\& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe. 1. There is plaque in the form of a film attached to the free gingival margin and adjacent tooth surface, which cannot be noticed with the naked eye, but can be seen with the help of a probe. 2. There is moderate plaque in the gingival pocket and on the tooth surface adjacent to the gingival margin, which can be seen with the naked eye. 3. There is dense plaque on the gingival pocket and the tooth surface adjacent to the gingival margin, the interdental area is completely filled with plaque.

  Change from plak index at 3 months

• Plaque İndex

  According to the plaque index (Silness\& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe. 1. There is plaque in the form of a film attached to the free gingival margin and adjacent tooth surface, which cannot be noticed with the naked eye, but can be seen with the help of a probe. 2. There is moderate plaque in the gingival pocket and on the tooth surface adjacent to the gingival margin, which can be seen with the naked eye. 3. There is dense plaque on the gingival pocket and the tooth surface adjacent to the gingival margin, the interdental area is completely filled with plaque.

  Change from plak index at 6 months

• Gingival index

  According to the gingival index (Löe\&Silness, 1963): 0: Healthy gingiva 1. There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. 2. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. 3. Severe inflammation, significant redness and edema are present, ulceration may be observed, a tendency to spontaneous bleeding may be observed.

  baseline gingival index

• Gingival index

  According to the gingival index (Löe\&Silness, 1963): 0: Healthy gingiva 1. There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. 2. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. 3. Severe inflammation, significant redness and edema are present, ulceration may be observed, a tendency to spontaneous bleeding may be observed.

  Change from gingival index at 1 month

• Gingival index

  According to the gingival index (Löe\&Silness, 1963): 0: Healthy gingiva 1. There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. 2. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. 3. Severe inflammation, significant redness and edema are present, ulceration may be observed, a tendency to spontaneous bleeding may be observed.

  Change from gingival index at 3 months

• Gingival index

  According to the gingival index (Löe\&Silness, 1963): 0: Healthy gingiva 1. There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. 2. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. 3. Severe inflammation, significant redness and edema are present, ulceration may be observed, a tendency to spontaneous bleeding may be observed.

  Change from gingival index at 6 months

• Probing Pocket Depth

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the free gingival margin was measured in millimeters.

  baseline Probing Pocket Depth

• Probing Pocket Depth

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the free gingival margin was measured in millimeters.

  Change from Probing Pocket Depth at 1 month

• Probing Pocket Depth

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the free gingival margin was measured in millimeters.

  Change from Probing Pocket Depth at 3 months

• Probing Pocket Depth

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the free gingival margin was measured in millimeters.

  Change from Probing Pocket Depth at 6 months

• Keratinized Gingival Amount

  The distance from the free gingival margin to the mucogingival junction was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  baseline Keratinized Gingival Amount

• Keratinized Gingival Amount

  The distance from the free gingival margin to the mucogingival junction was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  Change from keratinized gingival amount at 1 months

• Keratinized Gingival Amount

  The distance from the free gingival margin to the mucogingival junction was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  Change from keratinized gingival amount at 3 months

• Keratinized Gingival Amount

  The distance from the free gingival margin to the mucogingival junction was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  Change from keratinized gingival amount at 6 months

• Attached Gingival Amount

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the distance from the pocket base projection to the mucogingival junction was measured in millimeters.

  baseline attached gingival amount

• Attached Gingival Amount

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the distance from the pocket base projection to the mucogingival junction was measured in millimeters.

  Change from attached gingival amount at 1 months

• Attached Gingival Amount

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the distance from the pocket base projection to the mucogingival junction was measured in millimeters.

  Change from attached gingival amount at 3 months

• Attached Gingival Amount

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the distance from the pocket base projection to the mucogingival junction was measured in millimeters.

  Change from attached gingival amount at 6 months

• Gingival Recession Amount

  The distance from the enamel-cementum border to the free gingival margin was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  baseline gingival recession amount

• Gingival Recession Amount

  The distance from the enamel-cementum border to the free gingival margin was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  Change from gingival recession amount at 1 months

• Gingival Recession Amount

  The distance from the enamel-cementum border to the free gingival margin was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  Change from gingival recession amount at 3 months

• Gingival Recession Amount

  The distance from the enamel-cementum border to the free gingival margin was measured in millimeters with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  Change from gingival recession amount at 6 months

• Clinical Attachment Level

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the enamel junction was measured in millimeters.

  baseline clinical attachment level

• Clinical Attachment Level

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the enamel junction was measured in millimeters.

  Change from clinical attachment level amount at 1 months

• Clinical Attachment Level

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the enamel junction was measured in millimeters.

  Change from clinical attachment level amount at 3 months

• Clinical Attachment Level

  With a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA), the probe was inserted until a slight resistance was felt at the base of the pocket/sulcus, and the distance from the base of the pocket/sulcus to the enamel junction was measured in millimeters.

  Change from clinical attachment level amount at 6 months

• Gingival Thickness

  The distance from the 2 mm apical gingival margin to the hard tissue was measured in millimeters by inserting a 0.5 mm deep William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA) into the gingiva under topical anesthesia and completed to the nearest value.

  baseline gingival thickness

• Gingival Thickness

  The distance from the 2 mm apical gingival margin to the hard tissue was measured in millimeters by inserting a 0.5 mm deep William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA) into the gingiva under topical anesthesia and completed to the nearest value.

  Change from gingival thickness amount at 6 months

• Gingival Recession Width

  The mesio-distal width of the gingival recession at the level of the enamel-cementum border of the tooth was measured millimetrically with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  baseline gingival recession width

• Gingival Recession Width

  The mesio-distal width of the gingival recession at the level of the enamel-cementum border of the tooth was measured millimetrically with a 0.5 mm diameter William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA).

  Change from gingival recession width at 6 months

• Percentage of Root Surface Coverage (%)

  Baseline GRA - Postoperative 6th month GRA RCP (%) = --------------------- X 100 Baseline GRA

  It was calculated using the formula at 6 months after surgical procedures.

Study Arms (2)

Control group (FGG)

EXPERIMENTAL

The patients in this group only underwent the FGG operation.

Procedure: free gingival graft

Study group (FGG+BTX)

ACTIVE COMPARATOR

The patients in this group received 5 U BTX-A injection into the mental muscle immediately after the FGG operation.

Other: BTX-A; Procedure: free gingival graft

Interventions

BTX-A OTHER

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

Also known as: 100 U Allergan Botox®, Allergan, Inc., Irvine, California, Botox

Study group (FGG+BTX)

free gingival graft PROCEDURE

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

Control group (FGG); Study group (FGG+BTX)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• systemically healthy
• Not having the habit of using drugs that may adversely affect wound healing
• Non-mobile teeth
• No previous surgical intervention in the operation area
• No smoking habit.

You may not qualify if:

• Pregnant women and
• Women in the lactation period
• Mobile teeth

Sponsors & Collaborators

• Kevser Sokmen: lead

Study Sites (1)

Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology

Antalya, 07490, Turkey (Türkiye)

Location

Related Publications (9)

• Goyal L, Gupta ND, Gupta N, Chawla K. Free Gingival Graft as a Single Step Procedure for Treatment of Mandibular Miller Class I and II Recession Defects. World J Plast Surg. 2019 Jan;8(1):12-17. doi: 10.29252/wjps.8.1.12..

  PMID: 30873357 BACKGROUND

• Dias JJ, Panwar M, Kosala M. Management of inadequate keratinized gingiva and millers class III or IV gingival recession using two-stage free gingival graft procedure. J Indian Soc Periodontol. 2020 Nov-Dec;24(6):554-559. doi: 10.4103/jisp.jisp_531_19. Epub 2020 Nov 14.

  PMID: 33424173 BACKGROUND

• AlJasser RN, AlSarhan MA, AlOtaibi DH, AlOraini S, AlNuwaiser R, AlOtaibi A, Alduraihem H, Habib SR, Zafar MS. Comparison of Polymeric Cyanoacrylate Adhesives with Suturing in Free Gingival Graft Stability: A Split Mouth Trial. Polymers (Basel). 2021 Oct 16;13(20):3575. doi: 10.3390/polym13203575.

  PMID: 34685335 BACKGROUND

• Freeman SR, Cohen JL. New neurotoxins on the horizon. Aesthet Surg J. 2008 May-Jun;28(3):325-30. doi: 10.1016/j.asj.2008.03.006.

  PMID: 19083544 BACKGROUND

• Serrera-Figallo MA, Ruiz-de-Leon-Hernandez G, Torres-Lagares D, Castro-Araya A, Torres-Ferrerosa O, Hernandez-Pacheco E, Gutierrez-Perez JL. Use of Botulinum Toxin in Orofacial Clinical Practice. Toxins (Basel). 2020 Feb 11;12(2):112. doi: 10.3390/toxins12020112.

  PMID: 32053883 BACKGROUND

• Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5.

  PMID: 27997734 BACKGROUND

• Kim TK, Oh EJ, Chung JY, Park JW, Cho BC, Chung HY. The effects of botulinum toxin A on the survival of a random cutaneous flap. J Plast Reconstr Aesthet Surg. 2009 Jul;62(7):906-13. doi: 10.1016/j.bjps.2007.12.034. Epub 2008 Apr 24.

  PMID: 18436495 BACKGROUND

• Hull M, Parnes M. Effective Treatment of Geniospasm: Case Series and Review of the Literature. Tremor Other Hyperkinet Mov (N Y). 2020 Aug 17;10:31. doi: 10.5334/tohm.141.

  PMID: 32874771 BACKGROUND

• Papel ID, Capone RB. Botulinum toxin A for mentalis muscle dysfunction. Arch Facial Plast Surg. 2001 Oct-Dec;3(4):268-9. doi: 10.1001/archfaci.3.4.268.

  PMID: 11710863 BACKGROUND

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 Officials

• Kevser Sökmen, asst. prof.

  kevser.sokmen@alanya.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asisstant Professor

Model Details: The study was carried out on 40 lower incisors of 40 patients who applied to the Fırat University Faculty of Dentistry Department of Periodontology between the years of 2019 and 2021, who had Miller class III gingival recession in their lower 1st incisors, and were treated with FGG operation due to insufficient amount of keratinized gingiva. The patients were divided into 2 groups as randomized controlled. Control group (FGG) (n:20): The patients in this group only underwent the FGG operation. Study group (FGG+BTX) (n:20): The patients in this group received 5 U BTX-A injection into the mental muscle immediately after the FGG operation.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 20, 2023
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: may remain open indefinitely
• Access Criteria: everyone

Locations

TU (1)