Gingival Recession, Localized Clinical Trial
Official title:
Retrospective Evaluation Of The Effect Of Botulinum Toxin-A Injection Applied To The Mental Muscle On Free Gingival Graft Operation: A Randomized Controlled Clinical Study
Verified date | April 2023 |
Source | Alanya Alaaddin Keykubat University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18-65 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. Exclusion Criteria: - Pregnant women and - Women in the lactation period - Mobile teeth |
Country | Name | City | State |
---|---|---|---|
Turkey | Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology | Antalya |
Lead Sponsor | Collaborator |
---|---|
Kevser Sokmen |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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.. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plaque Index | According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
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. 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. 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 | |
Primary | Plaque Index | According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
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. 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. 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 | |
Primary | Plaque Index | According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
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. 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. 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 | |
Primary | Plaque Index | According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
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. 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. 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 | |
Primary | Gingival index | According to the gingival index (Löe&Silness, 1963):
0: Healthy gingiva There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. Severe inflammation, significant redness and edema are present, ulceration may be observed, a tendency to spontaneous bleeding may be observed. |
baseline gingival index | |
Primary | Gingival index | According to the gingival index (Löe&Silness, 1963):
0: Healthy gingiva There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. 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 | |
Primary | Gingival index | According to the gingival index (Löe&Silness, 1963):
0: Healthy gingiva There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. 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 | |
Primary | Gingival index | According to the gingival index (Löe&Silness, 1963):
0: Healthy gingiva There is mild inflammation of the gingiva, slight discoloration and edema, but no bleeding on probing. Moderate inflammation is observed, the gingiva is red, edematous and it is shiny, there is bleeding on probing. 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05591326 -
The Effect of Using Injectable Platelet-rich Fibrin on Root Surface Closure in Patients With Gingival Recession.
|
N/A | |
Recruiting |
NCT06000228 -
Effect of Vestibular Depth on Predictability of Miller Class III/ RT2 Gingival Recession Coverage
|
N/A | |
Recruiting |
NCT05563428 -
Free Gingival Graft Versus Connective Tissue Graft
|
N/A | |
Completed |
NCT04854902 -
Cyanoacrylate Use in Free Gingival Graft
|
N/A | |
Active, not recruiting |
NCT05682274 -
Effect of Restoration Margin Level in the Treatment of Gingival Recession Associated With Non-carious Cervical Lesion
|
N/A | |
Not yet recruiting |
NCT04729569 -
Gingival Response and Marginal Adaptation of Zirconia Crowns With Two Subgingival Margin Designs
|
N/A | |
Not yet recruiting |
NCT06228534 -
Root Coverage With Tunneling Technique With Connective Tissue Versus Coronal Advancement Flap Technique.
|
N/A | |
Completed |
NCT06197893 -
Modified Sling and Conventional Suture Techniques in Free Gingival Graft Operations
|
N/A | |
Recruiting |
NCT05850065 -
Assessment of Gingival Health Following Rubber-Dam Isolation
|
N/A | |
Completed |
NCT04718545 -
Effectiveness of Modified-free Gingival Graft for Treatment of Localized Gingival Recession Defects
|
N/A | |
Recruiting |
NCT05990049 -
Hyaluronic Acid and Free Gingival Graft Healing
|
Phase 3 | |
Completed |
NCT03425695 -
Free Gingival Graft Adjunct With Low Level Laser Therapy
|
N/A | |
Completed |
NCT06373783 -
Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage
|
N/A | |
Not yet recruiting |
NCT06030947 -
Effectiveness of Meshed Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects
|
N/A | |
Not yet recruiting |
NCT06432439 -
Impact of Microneedling on Coverage of RT1 Gingival Recession in Thin Phenotype.
|
N/A | |
Enrolling by invitation |
NCT06065774 -
Comparing Two Different Tunneling Technique for Gingival Recession Treatment Using Two Different Matertial
|
N/A | |
Recruiting |
NCT06404762 -
Tuberosity Versus Palatal Connective Tissue Graft on the Treatment of Single Maxillary Recession-type Defects
|
N/A | |
Completed |
NCT04198376 -
The Laterally Closed Tunnel Versus Modified Coronally Advanced Tunnel for Mandibular Anterior Gingival Recession Defects
|
N/A | |
Completed |
NCT03200392 -
Er,Cr:YSGG Laser For Recipient Bed Bio-modification And Connective Tissue Harvesting in Treatment of Gingival Recession
|
N/A | |
Enrolling by invitation |
NCT06388447 -
Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline
|
Phase 4 |