Clinical trial NCT06173739: Peri-implant Phenotype, Calprotectin and Mmp-8 Levels in Cases Diagnosed With Peri-implant Disease
Official title: The Effect of Peri-Implant Soft Tissue Phenotype on the Severity of Peri-Implant Diseases and the Outcomes of Non-Surgical Mechanical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Peri-Implantitis
Keywords: peri-implant disease
calprotectin
phenotype
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Then, traditional mechanical debridement with titanium curettes will be applied to areas with peri-implant disease. The area will be irrigated with physiological saline from time to time. Following the procedure, patients will be called for control at the 1st, 3rd and 6th months. Oral hygiene instructions will be repeated when necessary. At the 6th month, all clinical parameters examined will be measured again and PICF samples will be collected again.

All procedures will be performed by the same researcher. After the target number of patients is reached, the PICF samples collected will be sent to the laboratory for analysis using ELISA (Enzyme-linked immunosorbent assay) kits. Statistical analysis will be performed and interpreted for the features emphasized.

Eligibility criteria: Inclusion Criteria:

* -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.

Exclusion Criteria:

* Any drug allergy,

  * Pregnant or breastfeeding,
  * smoker
  * Having a systemic disability,
  * Peri-implant disease requiring advanced surgical techniques for treatment
  * Individuals who are not volunteers

Primary outcomes:
measure: Probing Depth(PD)
timeFrame: Immediately before procedure
measure: Probing Depth(PD)
timeFrame: After 6 months procedure
measure: Gingival Index (GI)
timeFrame: Immediately before procedure
measure: Gingival Index (GI)
timeFrame: After 6 months procedure
measure: Plaque Index(PI)
timeFrame: Immediately before procedure
measure: Plaque Index(PI)
timeFrame: After 6 months procedure
measure: Bleeding on Probing (BOP)
timeFrame: Immediately before procedure
measure: Bleeding on Probing (BOP)
timeFrame: After 6 months procedure
measure: Clinical Attachment Level (CAL)
timeFrame: Immediately before procedure
measure: Clinical Attachment Level (CAL)
timeFrame: After 6 months procedure
measure: Calprotectin (CAL)
timeFrame: Immediate before procedure
measure: Calprotectin (CAL)
timeFrame: After 6 months procedure
measure: Matrix Metalloproteinaz-8(MMP-8)
timeFrame: Immediate before procedure
measure: Matrix Metalloproteinaz-8(MMP-8)
timeFrame: After 6 months procedure
Secondary outcomes:
measure: Peri-implant phenotype
timeFrame: Before non-surgical mechanical treatment
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl Unıversity
Study officials:
References:
citation: Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.