- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822323
Effect of Botulinum Toxin-A on Free Gingival Graft
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION The FGG operation is a versatile surgical procedure that is frequently used in the treatment of gingival recessions to increase the width of the attached gingiva, the depth of the vestibule and to close the open root surface. While it is a more successful method in closing the open root surface in patients with Miller class I and II gingival recessions without bone loss, the same success cannot be observed in patients with Miller class III and IV gingival recessions with bone loss in the interdental area. The most important factors affecting the success of the FGG operation are the ensurement of the nourishment of the graft by maintaining the blood supply and the ensurement of graft immobility in the early recovery period by blocking the return of the dissected muscle attachments to their original position. Insufficient blood supply to the recipient bed where the graft is placed causes necrosis in the graft. In this case, there is a risk that the root surface cannot be completely covered. In addition, due to the desire of the dissected muscle attachments to return to their original position, there is a risk of not being able to achieve the desired amount of keratinized band increase.
Botox (BTX) is a toxin obtained from the Clostridium Botulinum bacteria and is a microbial protein that shows its effect by blocking neuromuscular activity. Immunologically, there are 8 different serotypes of BTX (A, B, C1, C2, D, E, F, G). Serotype A is the most potent serotype and the first form used in medicine. BTX-A is an agent used in medicine and dentistry for therapeutic purposes as well as cosmetic purposes. In the field of dentistry, it is preferred as a treatment method in many pathological conditions such as oromandibular dystonia, bruxism, asymmetry due to facial paralysis, temporomandibular joint (TMJ) disorders, gummy smile, and orange peel-looking jaw. There are studies showing that BTX application causes vasodilation in the blood vessels of the injected area; increasing the amount of blood flow and oxygen delivery at the vascular, tissue, cell and molecular levels in the region. It has been reported that this effect eliminates the risk of the necrosis of the graft whose blood connection was cut due to the increased blood supply in the region and also contributes to flap viability.
The mental muscle is a pair of muscles on the right and left, starting from the jawbone at the apical level of the incisors, moving downwards, and ending at the skin. The contraction of the mental muscle, which provides the vertical support of the lower lip; raises the lower lip and chin, creating a sullen and sad expression on the face. Due to the mental muscle ending at the skin, excessive activity of the muscle causes an indented appearance of the chin, which is called the orange peel. BTX injection applied to the mental muscle contributes to the improvement of the orange peel appearance by reducing the excessive activity of the muscle.
The aim of this retrospective study was to evaluate the effects of BTX-A injection to the mental muscle on patients with Miller class III gingival recession in their lower 1st incisors who underwent the FGG operation due to insufficient keratinized gingiva, on the basis of clinical periodontal parameters. Due to the fact that BTX-A injection applied to the mental muscle increases the blood supply of the region and decreases mental muscle activity suggests that it will positively affect the clinical periodontal parameters.
MATERIAL AND METHODS This study, which was approved by the Ethics Committee of Fırat University Medical Faculty Clinical Research Ethics Committee with the number 12/27 on 01.08.2019, was supported by the Fırat University Scientific Research Projects Management Unit with the project number DHF.19.10.
Study Population 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 Design In order to maintain the standardization of the study; it was made sure that the FGG operation, which is one of the treatment methods for gingival recession, and the BTX-A injection applied to the mental muscle were performed by the same physician (KS). In order to eliminate biased behavior, an experienced physician (TTY) who did not know which group the patients belonged to performed all clinical periodontal measurements. The study was terminated after the retrospective evaluation of the clinical periodontal parameters recorded in the patient follow-up forms at the baseline, 1st, 3rd and 6th month of the study period.
Clinical Procedure Non-Surgical Periodontal Treatment In this retrospective evaluation study; patients included were applied phase I periodontal treatment (detertrage and subgingival curettage), which is routinely applied in the clinic, before each surgical procedure and were also given oral hygiene training. The study protocol was explained to patients undergoing the FGG operation and FGG+BTX application and written informed consent was obtained from each individual prior to clinical periodontal examination.
Clinical Measurements PI, GI, PPD, KGA, AGA, CAL, GRA, GRW levels were measured at the baseline and at the postoperative 1st, 3rd and 6th month; GT parameters were measured at the baseline and the postoperative 6th month with a William's type periodontal probe (Nordent Manufacturing Inc, Elk Grove Village, IL, USA) with a 0.5 mm diameter. The RCP (%) was calculated using the formula below at the postoperative 6th month.
Baseline GRA - Postoperative 6th month GRA RCP (%) = --------------------- X 100 Baseline GRA
In order to provide standardization, clinical measurements of the study area were obtained from the reference point chosen as the midbuccal surface. In cases where the FGG operation was performed on both lower first incisors, one of the teeth were chosen at the baseline and measurements were made from the same tooth throughout the study period.
Surgical Procedure The surgical procedure was started by applying infiltrative local anesthesia (2% lidocaine, 1/100.000 epinephrine) to the operation area. The initial horizontal incision was made on the Mucogingival line with a number 15 scalpel. This incision was deepened in the apical direction with sharp dissections. The recipient bed size was prepared in accordance with the graft size which was determined as 7 mm in the apico-coronal direction and with a distance of 3 mm from the graft edges in all directions. Deepitelization of the gingiva remaining in the coronal part and root surface straightening of the lower incisors were performed. The recipient bed preparation was completed by washing the operation area with 0.9% sterile saline. The graft area was determined as the palatal region, which does not contain rugae, between the mesial of the first molar and the distal of the canine in the upper jaw. After local infiltrative anesthesia (2% lidocaine, 1/100.000 epinephrine) application to the palate region, the graft was obtained with a number 15 scalpel. Bleeding in the palate area was controlled by applying pressure with moist gauze for 5 minutes. The excess fat tissue on the inner surface of the graft was cleaned on a moist sponge with a sharp scalpel or curved-tipped tissue scissors and the fixation phase was started at the recipient site. The graft was fixed to the recipient bed with the minimum number of monofilament non-resorbable 5-0 polypropylene (Katsan, İzmir, Turkey) sutures at the most coronal region of the crestal bone. 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. Amoxicillin + clavulanic acid 1000 mg (2 times a day), dexketoprofen 25 mg (2 times a day) and 0.12% chlorhexidine gluconate mouthwash (3 times a day) were prescribed to each patient to control the risk of post-operative pain and infection. It was recommended that the patients brush the areas other than the operation site 2 times a day, 1 day after the operation. It was recommended to gently clean the graft surface with the help of a cotton swab soaked in mouthwash. The sutures were removed on the post-operative 21st day. Photographs of the recipient area were recorded at the baseline and the postoperative 1st, 3rd, and 6th month of each patient included in the study.
Statistical Reviews While evaluating the recorded findings in this retrospective study, the IBM SPSS Statistics 22 program was used for statistical analysis. The suitability of the parameters to the normal distribution was evaluated with Kolmogorov-Smirnov and Shapiro Wilks tests and was determined that the parameters did not show normal distribution. The Mann Whitney U test was used for the comparison of the parameters between the two groups, and the Friedman test (post hoc Wilcoxon sign test) was used for comparisons within each group. Spearman's rho correlation analysis was used to evaluate the correlations between the parameters. Significance was evaluated at the p<0.05 level.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Antalya, Turkey, 07490
- Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Periodontology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Control group (FGG)
The patients in this group only underwent the FGG operation.
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The mandibular first incisor was treated with FGG operation due to Miller class III gingival recession and insufficient amount of keratinized gingiva.
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Active Comparator: Study group (FGG+BTX)
The patients in this group received 5 U BTX-A injection into the mental muscle immediately after the FGG operation.
|
The mandibular first incisor was treated with FGG operation due to Miller class III gingival recession and insufficient amount of keratinized gingiva.
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque İndex
Time Frame: baseline plaque index
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According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
|
baseline plaque index
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Plaque İndex
Time Frame: Change from plak index at 1 months
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According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
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Change from plak index at 1 months
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Plaque İndex
Time Frame: Change from plak index at 3 months
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According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
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Change from plak index at 3 months
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Plaque İndex
Time Frame: Change from plak index at 6 months
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According to the plaque index (Silness& Löe, 1964); 0: There is no plaque on the gingival margin when visualized and examined with a probe.
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Change from plak index at 6 months
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Gingival index
Time Frame: baseline gingival index
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According to the gingival index (Löe&Silness, 1963): 0: Healthy gingiva
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baseline gingival index
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Gingival index
Time Frame: Change from gingival index at 1 month
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According to the gingival index (Löe&Silness, 1963): 0: Healthy gingiva
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Change from gingival index at 1 month
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Gingival index
Time Frame: Change from gingival index at 3 months
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According to the gingival index (Löe&Silness, 1963): 0: Healthy gingiva
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Change from gingival index at 3 months
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Gingival index
Time Frame: Change from gingival index at 6 months
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According to the gingival index (Löe&Silness, 1963): 0: Healthy gingiva
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Change from gingival index at 6 months
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Probing Pocket Depth
Time Frame: baseline 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.
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baseline Probing Pocket Depth
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Probing Pocket Depth
Time Frame: Change from Probing Pocket Depth at 1 month
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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.
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Change from Probing Pocket Depth at 1 month
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Probing Pocket Depth
Time Frame: Change from Probing Pocket Depth at 3 months
|
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.
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Change from Probing Pocket Depth at 3 months
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Probing Pocket Depth
Time Frame: Change from Probing Pocket Depth at 6 months
|
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.
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Change from Probing Pocket Depth at 6 months
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Keratinized Gingival Amount
Time Frame: baseline Keratinized Gingival Amount
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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
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Keratinized Gingival Amount
Time Frame: Change from keratinized gingival amount at 1 months
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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).
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Change from keratinized gingival amount at 1 months
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Keratinized Gingival Amount
Time Frame: Change from keratinized gingival amount at 3 months
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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).
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Change from keratinized gingival amount at 3 months
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Keratinized Gingival Amount
Time Frame: Change from keratinized gingival amount at 6 months
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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).
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Change from keratinized gingival amount at 6 months
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Attached Gingival Amount
Time Frame: baseline attached gingival amount
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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.
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baseline attached gingival amount
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Attached Gingival Amount
Time Frame: Change from attached gingival amount at 1 months
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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.
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Change from attached gingival amount at 1 months
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Attached Gingival Amount
Time Frame: Change from attached gingival amount at 3 months
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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.
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Change from attached gingival amount at 3 months
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Attached Gingival Amount
Time Frame: Change from attached gingival amount at 6 months
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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.
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Change from attached gingival amount at 6 months
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Gingival Recession Amount
Time Frame: baseline gingival recession amount
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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).
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baseline gingival recession amount
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Gingival Recession Amount
Time Frame: Change from gingival recession amount at 1 months
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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).
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Change from gingival recession amount at 1 months
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Gingival Recession Amount
Time Frame: Change from gingival recession amount at 3 months
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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).
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Change from gingival recession amount at 3 months
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Gingival Recession Amount
Time Frame: Change from gingival recession amount at 6 months
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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).
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Change from gingival recession amount at 6 months
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Clinical Attachment Level
Time Frame: baseline clinical attachment level
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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
Time Frame: Change from clinical attachment level amount at 1 months
|
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.
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Change from clinical attachment level amount at 1 months
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Clinical Attachment Level
Time Frame: Change from clinical attachment level amount at 3 months
|
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
Time Frame: Change from clinical attachment level amount at 6 months
|
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.
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Change from clinical attachment level amount at 6 months
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Gingival Thickness
Time Frame: baseline gingival thickness
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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.
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baseline gingival thickness
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Gingival Thickness
Time Frame: Change from gingival thickness amount at 6 months
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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.
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Change from gingival thickness amount at 6 months
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Gingival Recession Width
Time Frame: baseline gingival recession width
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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).
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baseline gingival recession width
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Gingival Recession Width
Time Frame: Change from gingival recession width at 6 months
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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).
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Change from gingival recession width at 6 months
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Percentage of Root Surface Coverage (%)
Time Frame: It was calculated using the formula at 6 months after surgical procedures.
|
Baseline GRA - Postoperative 6th month GRA RCP (%) = --------------------- X 100 Baseline GRA
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It was calculated using the formula at 6 months after surgical procedures.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevser Sökmen, asst. prof., kevser.sokmen@alanya.edu.tr
Publications and helpful links
General Publications
- 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.
- 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..
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Gingival Diseases
- Periodontal Atrophy
- Gingival Recession
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- AlanyaAKÜ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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