Peri-implant Phenotype, Calprotectin and Mmp-8 Levels in Cases Diagnosed With Peri-implant Disease
Condition: Peri-implant Mucositis; Peri-Implantitis
MeSH terms: Mucositis; Peri-Implantitis
Study type: Interventional

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.
    

Intervention name(s): Non-surgical mechanical treatment
Intervention type(s): Procedure
Intervention description(s): Nonsurgical mechanical therapy (NSMT) aims to control infection and minimize bacterial burden through debridement of the implant surface. It is the gold standard treatment method for both peri-implantitis and peri-implant mucositis.
Non-surgical mechanical treatment will be applied to patients with the purpose of surface debridement and reducing bacterial flora in implants with peri-implant disease for which clinical examination has been completed and the diagnosis has been confirmed. All intraoral implants of the patients will be evaluated and all implants that do not meet the clinical definition of health will be intervened. Each implant surface will be treated with a titanium curette. In all groups, mechanical debridement was performed on the surfaces by the same clinician.
The procedure will continue gently until it is felt that it has been adequately debrided. Subgingival irrigation will be performed with physiological saline. Post NSMT No medication will be administered.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: peri-implant disease; calprotectin; phenotype