Radiological Bone Loss on Different Levels of Dental Implants
Condition: Alveolar Bone Loss; Peri-Implantitis; Bone Loss in Jaw
MeSH terms: Bone Diseases, Metabolic; Alveolar Bone Loss; Peri-Implantitis
Study type: Interventional

Summary: 
      One of the criteria used for long-term implant success is the evaluation of radiographic bone
      loss. It is known that the keratinized mucosa over the alveolar crest forms a protective
      barrier against inflammatory infiltration. In addition, it has been reported that the
      vertical mucosal thickness on the crest is important in the formation of the biological width
      around the implant. The aim of this study was to evaluate the effect of vertical mucosal
      thickness on the alveolar crest on peri-implant marginal bone loss around crestal and
      subcrestal placed platform-switching implants. In this study, patients will be divided into 2
      main groups with vertical mucosal thickness of 2 mm and less and more than 2 mm, and both
      groups will consist of 2 subgroups as crestally and subcrestally according to the implant
      level placed. A total of 80 implants will be included, 20 implants in each group. Before
      starting the surgery, after anesthesia is given, the width of the patient's peri-implant
      keratinized mucosa and the vertical mucosal thickness over the alveolar crest will be
      measured. Clinical and radiological measurements will be made in all patients during the
      prosthetic loading session (T0), at 3rd month (T1), 6th month (T2) and 1 year after loading
      (T3). With standardized control periapical radiographs to be taken as a result of one-year
      follow-up, the marginal bone loss amount in the implants will be evaluated using soft-ware.
    

Detailed description: 
      Dental implants have become one of the most common treatments used for the rehabilitation of
      lost teeth. The success rate of dental implant treatment is quite high. One of the criteria
      used for long-term implant success is the evaluation of radiographic bone loss. It is known
      that the keratinized mucosa over the alveolar crest forms a protective barrier against
      inflammatory infiltration. It has been reported that the vertical mucosal thickness over the
      alveolar crest in the operation area before dental implant treatment is important in the
      formation of the biological width around the implant. There are studies in the literature
      examining the effects of vertical mucosal thickness on peri-implant marginal bone loss. In a
      study presented by Linkevicius et al., in 2014, they divided 80 patients into 2 groups
      according to their mucosal thickness. It was reported that radiological bone loss was 1.17 mm
      in the group with low vertical mucosal thickness at the end of 1-year follow-up, and 0.21 mm
      in the group with high vertical thickness.

      The aim of the study was to evaluate the effect of vertical mucosal thickness on the alveolar
      crest on peri-implant marginal bone loss around crestal and subcrestal placed
      platform-switching implants.

      Before starting the surgery, after the patient is anesthetized, the width of the peri-implant
      keratinized mucosa and the vertical mucosal thickness over the alveolar crest will be
      measured. In this study, patients will be divided into 2 main groups with vertical mucosal
      thickness of 2 mm and less and more than 2 mm, and both groups will consist of 2 subgroups as
      crestal and subcrestal according to the implant level placed.

      It is planned to use the same brand of implant and platform-switch abutment in patients. With
      standardized control periapical radiographs to be taken as a result of one-year follow-up,
      the marginal bone loss amount in the implants will be evaluated using software. Routine
      clinical and radiological measurements will be repeated in all patients at the prosthetic
      loading session (T0), at 3 months (T1), at 6 months (T2), and 1 year after loading (T3).
      Pre-surgical radiographs will be taken from the patients who participated in our study, as in
      all implant patients Clinical measurements.

        1. Plaque index (Löe & Silness) and gingival index (Silness & Löe) are obtained by
           measuring 4 regions of a tooth (mesial, distal, buccal and lingual) with a Williams
           periodontal probe.

           Attachment loss: It is the value of the distance between a tooth and the free gingiva,
           based on the enamel-cementum junction, measured using a Williams periodontal probe.

        2. Bleeding on probing index (Ainamo & Bay): In this index, probing is performed by gently
           walking around the pocket. As a result of probing, the evaluation is made by looking at
           the presence or absence of bleeding in the gingiva. A positive value is given if
           bleeding occurs within 10-15 seconds after probing in the mesial, distal, buccal and
           lingual gingival parts of all teeth. The ratio of the bleeding area to the examined area
           is expressed as %.

        3. Keratinized gingival width: It is the distance from the free gingival margin to the
           mucogingival junction line.

        4. Vertical mucosal thickness: It is the distance from the apex of the alveolar crest to
           the gingival margin. It will be measured with a standardized William type probe.

        5. Pocket depth: The vertical distance between the base of the periodontal sulcus and the
           gingival margin with a standard periodontal probe.

        6. Peri-implant pocket depth: It is the vertical distance between the base of the
           peri-implant sulcus and the gingival margin.

        7. Marginal bone level: Radiographic evaluation of the distance between the restoration
           margin and the bone level.

      Sample Selection: Taking the effect size of 0.08 for the significance value in the G Power
      analysis program as a reference to a previously presented study, 60 implants were planned to
      be taken for α= 0.05 and 80% power. However, since the study is a long-term control study, it
      is planned to take 20 implants each, due to the risk of patients not coming to the control
      sessions. A total of 80 implants will be included.

      Statistical analysis method: All analyzes will be done with (Statistical Package for the
      Social Sciences) SPSS software. In-group temporal evaluations in test and control groups will
      be evaluated using Paired sample -T or Wilcoxon test according to normal distribution values.
      For comparisons between groups, the data will be analyzed by independent sample-T or Mann
      Whitney U test according to their normal distribution. The normal distribution of the data
      will be evaluated with the Kolmogorov-Smirnov test. The significance value will be taken as
      0.05. Relationships between variables will be evaluated with Logistic Regression Analysis or
      Multivariate Regression Analysis.
    

Intervention name(s): dental implant placement
Intervention type(s): Procedure
Intervention description(s): In dental implant placement surgery, first of all, intraoral infiltrative anesthesia is applied to the area. After the crestal incision, the buccal flap is elevated to full thickness. Vertical mucosal height is measured with a William type standard periodontal probe. The palatal/lingual flap is then elevated to full thickness. The implant is placed at different levels with the standard protocol determined by the manufacturer. Study groups are determined by the placement levels of the implants and the vertical mucosal height measurement values. After the implants are placed, the flap is closed primarily.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled, non-randomized, single-blind, parallel
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vertical mucosal height; dental implant; marginal bone loss; keratinized gingival width