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Completed

NCT Number: NCT03988140

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

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.

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Key information

Conditions

Diabetes Mellitus Dental Implants Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

59 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental Implant Placement and subsequent prosthetic reabilithation

Device

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.

Primary outcomes

  1. Change from baseline Peri-implant Probing Depth (PPD) at 24 months.

    Time frame: (baseline) and at 6, 12 and 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

Secondary outcomes

  1. Mucosal Margin (MM)

    Time frame: (baseline) and at 6, 12 and 24 months

    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

  2. Clinical attachment level (CAL)

    Time frame: (baseline) and at 6, 12 and 24 months

    calculated by adding PPD and MM measured by a calibrated examiner in millimeter using a Periodontal probing

  3. Modified Bleeding on Probing

    Time frame: (baseline) and at 6, 12 and 24 months

    dichotomous index of bleeding during probing around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.

  4. Modified Plaque Index

    Time frame: (baseline) and at 6, 12 and 24 months

    dichotomous modified plaque index along the mucosal margin around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.

  5. Crest Height Bone Marginal Peri-implant

    Time frame: (baseline) and at 6, 12 and 24 months

    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

  6. Markers on peri-implant crevicular fluid

    Time frame: (baseline) and at 6, 12 and 24 months

    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.

Sponsors and collaborators

Lead sponsor

Paulista University

Other

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2019
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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