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临床试验/NCT05822323
NCT05822323已完成不适用

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

Kevser Sokmen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Plaque İndex

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Plaque İndex

时间窗: Change from plak index at 6 months

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.

Gingival Recession Amount

时间窗: Change from gingival recession amount at 6 months

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).

Gingival Recession Width

时间窗: Change from gingival recession width at 6 months

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).

Gingival index

时间窗: Change from gingival index at 6 months

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.

Keratinized Gingival Amount

时间窗: Change from keratinized gingival amount at 6 months

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).

Probing Pocket Depth

时间窗: 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.

Attached Gingival Amount

时间窗: Change from attached gingival amount at 6 months

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.

Clinical Attachment Level

时间窗: 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.

Gingival Thickness

时间窗: Change from gingival thickness amount at 6 months

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.

Percentage of Root Surface Coverage (%)

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

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

次要结局

未报告次要终点

研究者

发起方
Kevser Sokmen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kevser Sokmen

Asisstant Professor

Alanya Alaaddin Keykubat University

研究点 (2)

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