Apico-coronal Position of the Implant in Edentulous Diabetics With Implant-retained Overdentures

Study Overview
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Brief Summary
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Diabetes Mellitus (DM) is a recognized factor affecting implant complication rates, including peri-implantitis and peri-implant bone loss, and the apico-coronal position of implants seems interfere on the conditions of peri-implant tissues. However, the influence of the vertical implant position in type 2 diabetics (T2DM) is unclear. This split-mouth randomized controlled trial evaluated the impact of implants of machined-collar placed at crestal level or supracrestally in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.

Detailed Description
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Considering the outcomes achieved with implants with machined-collar inserted supracrestally, it would be relevant to investigate whether this therapeutic strategy could be considered as a more effective approach in the rehabilitation with dental implants of individuals with type 2 DM, since these patients may be more disposed to peri-implant changes, both from the point of view of marginal bone remodeling as related to local variations in immunoinflammatory response. Thus, the propose of this split-mouth randomized controlled trial was to compare the impact of crestal level or supracrestally implant platform in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.

Official Title
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Could the Apico-coronal Position of the Implant Influence the Peri-implant Parameters in Mandibular Edentulous Type 2 Diabetics Rehabilitated With Implant-retained Overdentures? A Split-mouth RCT With 24-months Follow up.

Conditions
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Diabetes Mellitus, Dental Implants

Intervention / Treatment
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* Device: Dental Implant Placement and subsequent prosthetic reabilithation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria included: patients aged between 50 and 80 years old, 2) totally edentulous in the mandible with previous mandibular dentures for at least 6 months and indicated for rehabilitation with overdenture, 3) patients with diabetes had to have had T2DM, diagnosed by a physician, for at least the past 5 years. Such individuals were either under a dietary regimen and/or were using oral hypoglycaemic agents (metformin or glybenclamin). Exclusion Criteria: Exclusion criteria were: 1) pregnancy, 2) lactation, 3) current smoking or ex-smokers, 4) other systemic conditions that could affect bone metabolism (e.g., immunologic disorders), 5) use of anti-inflammatory, immunosuppressive and anti-resorptive medications, 6) patients that required bone grafts before or concomitantly with implant surgery and 7) a history of previous regenerative procedures in the area designated for implant therapy. Patients with major complications of DM (i.e., cardiovascular and peripheral vascular diseases [ulcers, gangrene, and amputation], neuropathy, and nephropathy) were also excluded.

Ages Eligible for Study
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Minimum Age: 59 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This study was designed as a prospective, split-mouth, randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant placed at supra crestal level (SL)<br>Implants were placed at supra crestal level (SL) | Device: Dental Implant Placement and subsequent prosthetic reabilithation<br>* Surgeries to dental implant placement were performed. All patients received 3.5 mm diameter dental implants - surface blasted with TiO2 particles and machined collar of 1mm - in the interforaminal region of the mandible. The surgical sequence followed the protocol described by the implant company.A two stages protocol was used and the prostheses were placed at 4 months.The prosthetic retention system used in rehabilitation with overdentures was the O'ring and the capture of this component was done directly in the patient's mouth. After 7 and 14 days, the patients returned to occlusal adjustments and verification of prosthetic adaptation. The prostheses were made entirely of acrylic resin without metallic reinforcement and the antagonist of the patients were total edentulous and rehabilitated with muco-supported prostheses.<br>|
| Other: Implant placed at crestal level (CL).<br>Implants were placed at crestal level (CL) | Device: Dental Implant Placement and subsequent prosthetic reabilithation<br>* Surgeries to dental implant placement were performed. All patients received 3.5 mm diameter dental implants - surface blasted with TiO2 particles and machined collar of 1mm - in the interforaminal region of the mandible. The surgical sequence followed the protocol described by the implant company.A two stages protocol was used and the prostheses were placed at 4 months.The prosthetic retention system used in rehabilitation with overdentures was the O'ring and the capture of this component was done directly in the patient's mouth. After 7 and 14 days, the patients returned to occlusal adjustments and verification of prosthetic adaptation. The prostheses were made entirely of acrylic resin without metallic reinforcement and the antagonist of the patients were total edentulous and rehabilitated with muco-supported prostheses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Peri-implant Probing Depth (PPD) at 24 months. | distance from the bottom of the peri-implant pocket (PPD) to the mucosal margin (MM) measured by a calibrated examiner in millimeter using a Periodontal probing | (baseline) and at 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal Margin (MM) | distance from the implant platform to the peri-implant margin (CL group) and distance from the machined collar maintained supracrestally to the peri-implant margin (SL group) measured by a calibrated examiner in millimeter using a Periodontal probing | (baseline) and at 6, 12 and 24 months | 
| Clinical attachment level (CAL) | calculated by adding PPD and MM measured by a calibrated examiner in millimeter using a Periodontal probing | (baseline) and at 6, 12 and 24 months | 
| Modified Bleeding on Probing | dichotomous index of bleeding during probing around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage. | (baseline) and at 6, 12 and 24 months | 
| Modified Plaque Index | dichotomous modified plaque index along the mucosal margin around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage. | (baseline) and at 6, 12 and 24 months | 
| Crest Height Bone Marginal Peri-implant | linear measurement in millimeter obtained by a parallel line to the implant surface from the implant platform to bone crestal (mesial, distal, buccal and lingually) in the sagittal and coronal slices each 2 mm using Cone Beam Computed Tomography (CBCT) scans | (baseline) and at 6, 12 and 24 months | 
| Markers on peri-implant crevicular fluid | The levels of Imunoinflammatory mediators: interferon (IFN)-gama, interleukin (IL)-10, IL-17, IL-33, IL-21, IL-4, IL-23, IL-6 and tumor necrosis factor (TNF)-α in the peri-implant crevicular fluid were determined using human plex and the multiplexing instrument. The mean concentration of each biomarker was calculated and expressed as pg/ml. | (baseline) and at 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental prosthesis, biological markers, dental implants