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,
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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. |
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