The Effect of Peri-Implant Soft Tissue Phenotype on the Severity of Peri-Implant Diseases and the Outcomes of Non-Surgical Mechanical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Calprotectin (CAL)
研究概览
简要总结
Following the implantation procedures; The peri-implant mucosa may begin to show signs of inflammation depending on the patient (bruxism, lack of oral hygiene) or other factors (planning errors, iatrogenic factors). These signs of inflammation may remain limited to soft tissue or may progress to bone depending on the host response. Another relevant factor in such cases is peri-implant mucosa thickness. Our study aims to investigate the effect of peri-implant soft tissue thickness on the degree of peri-implant disease and the contribution of soft tissue augmentation procedures applied with subepithelial connective tissue graft and non-surgical mechanical treatment results, accompanied by clinical and biochemical parameters.
详细描述
The study was carried out in Van Yüzüncü Yıl University Faculty of Dentistry, in patients who were diagnosed with inflammation or bone loss around their implants and were referred to Periodontology Department for the treatment of the relevant areas, aged between 18-65, systemically healthy, non-smokers, and without any drug allergies. and will be conducted on 50 volunteer individuals who do not require advanced surgical techniques. The peri-implant soft tissue phenotype of all participants who are detected to have peri-implant disease and will be included in the study will be measured, necessary clinical and radiological examinations will be performed, necessary samples will be collected and conventional mechanical treatments will be applied. The data of all participants will be collected again in the 6th month following the treatment. Study details are given below: Patients who will participate in the study will be explained the details of the application and the research to be conducted and will have to sign an informed consent form.
Detailed anamnesis of patients who meet the selection criteria will be taken and clinical and radiological examinations will be performed. Patients with caries on their teeth will be directed to Restorative Dentistry Department and restorations of existing caries will be made at the relevant clinic. Patients will be given oral hygiene training before the mechanical treatment of peri-implant diseases.
Peri-implant crevice fluid (PICF) samples will be collected before mechanical treatment of the diseased implant areas of individuals is initiated. The areas will be isolated from saliva with cotton pellets, dried with light air, and the paper strips will be kept in the trough for 30 seconds. Paper strips obtained from each implant will be placed in Eppendorf tubes containing isotonic Ph:7.4 phosphate buffer solution and stored at -40 ° C until analyzed in the laboratory department of our clinic.
Routine periodontal parameters such as plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level of the individuals whose PICF samples are collected will be measured and recorded with the help of Williams-type plastic probes.
Following these procedures, the patients; peri-implant phenotype will be evaluated. In the evaluation, the traditional transgingival probing technique and a newly developed technique will be used simultaneously and their correlations with each other will be examined. In the transgingival probing technique, measurements will be made from two points: apical of the free gingival groove and coronal of the mucogingival composition. After the peri-implant mucosa thickness measurement points are determined with a marker pen, Xylocaine® spray (Vemcaine 10%, lidocaine) or, if necessary, local anesthetic (Maxicaine, lidocaine hydrochloride) will be applied to prevent the patient from feeling pain. Measurements will be made from the marked points in a direction perpendicular to the peri-implant mucosa, using a 10-gauge endodontic spreader (G-Star Medical Co., Ltd., Guangdong, China) with a silicone stopper until its contact with the alveolar bone is felt. Since excessive force will cause the spreader to exceed the soft tissue and advance in the alveolar bone, care should be taken to apply only light forces that can be limited to the soft tissue. After all measurements are repeated twice by the same researcher at 10-minute intervals, the amount of peri-implant mucosa thickness in each region will be determined by taking the average of the two measurements. If the millimetric values obtained as a result of measurements are less than 1 mm, thin phenotype; If it is more than 1 mm, it will be classified as thick phenotype. The second gingival phenotype evaluation in individuals with peri-implant disease will be performed with the Hu-Friedy Colorvue Biotip Probe®, a newly developed probe with a colored tip that will be placed in the peri-implant pocket. The white probe will first be placed in the peri-implant pocket with a pressure of less than 25 N. If the color of the probe reflects from the gingival tissue, the phenotype will be recorded as thin. If the white color is not visible, the green probe will be placed in the pocket in the same way and if the color is reflected, the phenotype will be classified as medium thickness. If the Green tip is not visible through the gingival tissue, the Blue probe will be used and if the only color seen is Blue, the phenotype will be classified as thick. If blue is not visible, the peri-implant mucosa tissue will be recorded as too thick.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 否
入选标准
- •-Systemically healthy,
- •Non-smoker,
- •There is no drug allergy and no advanced surgical techniques are required.
- •39 volunteers, aged 18-65, who applied to the Department of Periodontics with complaints of infection around the implant or were referred to our clinic, will be included.
排除标准
- •Any drug allergy,
- •Pregnant or breastfeeding,
- •Having a systemic disability,
- •Peri-implant disease requiring advanced surgical techniques for treatment
- •Individuals who are not volunteers
结局指标
主要结局
Calprotectin (CAL)
时间窗: After 6 months procedure
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. In this method, the amount of CLP, a degradation protein, is calculated. CLP is an antimicrobial protein and inflammation marker.
Matrix Metalloproteinaz-8(MMP-8)
时间窗: After 6 months procedure
PICFs collected from the peri-implant margin with paper strips are analyzed by ELISA method. MMP-8 is currently used in the prediction, diagnosis, treatment prognosis and treatment of periodontal disease. It is considered one of the main biomarkers used for classification. On the other hand, effective periodontal treatment and MMP inhibitor adjuvant drugs are effective in the progression of periodontal disease by reducing the MMP-8 level in GCF (gingival crevicular fluid) and saliva. It has been shown to have inhibitory effects. Collagenase, which also plays a role in inflammation of peri-implant connective tissue, and gelatinases, with high levels of MMP-8 in peri-implant crevice fluid. has been associated. Low MMP-8 level was determined to indicate peri-implant health, while high regulation of MMP 8 showed inflammation.
Plaque Index(PI)
时间窗: After 6 months procedure
The area around the abutment to be measured was isolated with cotton pads and gently dried with air-water spray. Plaque was collected from around the groove or pocket with the help of a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland).
Bleeding on Probing (BOP)
时间窗: After 6 months procedure
The bleeding on probing score is the gold standard for detecting peri-implant diseases. If bleeding occurs after the probe is placed in the pocket, it is scored as positive (+), otherwise it is scored as negative (-).
Clinical Attachment Level (CAL)
时间窗: After 6 months procedure
CAL; It is defined as the distance from the cemento-enamel junction (CEJ) on tooth surfaces to the apical of the pocket base. In the presence of gingival recession; The gingival margin migrates apical to the CEJ. In this case, CAL; length of gingival recession and probing It is calculated as the sum of the depth.
Probing Depth(PD)
时间窗: After 6 months procedure
The depth of the peri-implant pocket or groove was measured with a plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) from 4 regions of the peri-implant mucosa: mesial, distal, lingual/palatinal and buccal. No extra force was applied to the plastic probe during measurement. The probe placed in the pocket was held parallel to the abutment with a force equal to its own weight (approximately 0.25 N). At the point where resistance is felt at the bottom of the pocket without losing contact with the implant surface; The value corresponding to the margin was recorded on the plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland). All measurement values were collected and averaged, and the average probing depth of the relevant implant was determined.
Gingival Index (GI)
时间窗: After 6 months procedure
The plastic probe (KERR- Hawe Caliber Plastic Periodontal Probe, Switzerland) is placed in the groove or pocket without pressure. bleeding from 4 regions (mesial, distal, lingual/palatinal and buccal) scoring was done. The gingival index score for the relevant implant is the total value Obtained by taking the average. Gingival index, inflammation in the peri-implant mucosa is one of the important indicators.
次要结局
- Peri-implant phenotype(Before non-surgical mechanical treatment)
研究者
Beliz Önder
Assistant Professor
Bilecik Seyh Edebali Universitesi
