Healing Profile of Titanium Dental Implants Placed in Patients With Diabetes
Condition: Type 2 Diabetes; Dental Implants
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main goal of this study is to look at the way gums heal around dental implants placed in
      healthy patients compared to patients with type 2 diabetes. This study is designed to answer
      the following questions:

        -  How much swelling occurs around dental implants placed in patients with type 2 diabetes?

        -  Is swelling (inflammation) present or absent in the initial healing phase after
           placement of dental implants?

        -  What are the differences in the amount of swelling (inflammation) in patients with and
           without type 2 diabetes? Are patients with type 2 diabetes more likely to have bone loss
           around dental implants?
    

Detailed description: 
      Rationale:

      For the evaluation/ monitoring of dental implants, practitioners seem to use simultaneously a
      variety of the clinical, image-based and laboratory measurements, probably because of the
      fact that each of these measures is likely to provide important information regarding the
      complex series of events at the dental implant sites (Guncu et al 2008). Thus, the proposed
      study seeks to characterize for the first time, the healing profile of dental implants in
      type 2 diabetic patients when compared with natural teeth, in the lights of the microarray
      quantitative evaluation of the host response promoted by cytokines and
      osteoclastogenesis-related factors levels, and correlates the quantitative findings with
      qualitative high-tech multi-modal clinical infra-red diagnosis data. This information may
      allow the development of new therapeutic intervention modalities to maximize the protective
      and minimize the destructive aspects of inflammation in peri-implant tissues even in early
      stages. If the results of this preliminary study are positive, a longitudinal follow-up study
      will be conducted within the same population to investigate this relationship over a
      long-term period.

      Methods:

      A 1-year prospective pilot study will be performed in 20 patients (males; 35-55 year old), 10
      controlled type 2 diabetics (HbA1c values < 7.2%) and 10 non diabetics matched for implant
      treatment indications to serve as controls (all suffering from partial edentulism). Patients
      will receive at least one dental implant (Ankylos®, Dentsply, Germany). Patients attending
      the Graduate Periodontics Clinic (University of Manitoba) will be invited to participate in
      the study. A comprehensive history will be taken and an examination of the oral cavity will
      be carried out for each patient for implant evaluation. Based on a review of the history and
      the examination findings by one of the study personnel, potential subjects will be identified
      who satisfy the following inclusion and exclusion criteria. Excluded from the study will be
      those with active periodontal disease, uncontrolled diabetes, smokers, any metabolic bone
      diseases or other systemic disorders. All patients will be informed about the nature of the
      study and volunteers will sign an informed consent form prior to entry into the study. The
      patients will receive at least 1 one-stage Ankylos® implant (Dentsply, Germany) in the same
      bone area. After restoration, the patients will be followed up for up to 1 year. The healing
      profile will be determined quantitatively by cytokines and biomarkers in peri-implant
      crevicular fluid (PICF) (microarray) and qualitatively by the inflammatory infiltrate (IR
      evaluation).

      Aims and Approaches:

      Aim 1- To establish quantitatively and qualitatively the healing profile of dental implants
      placed in type 2 diabetic patients.

      Aim 2- To compare the levels of cytokines between dental implants and natural teeth.

      Approach: PICF/GCF samples will be collected from diabetic and non diabetic patients. The
      volume of PICF/GCF will be determined (Periotron 8000®) for subsequent cytokine assays
      (Schierano et al 2008). All samples will be evaluated simultaneously by microarray technique
      (Genepix®) for quantitative measurement of the concentration of multiple cytokines: IL-1β,
      IL-2, IL-4, IL-6, IL-8, TNF-α, IFN-γ, IL-10, IL-12p70, IL-13, TGF-β, IL-17 and IL-23, as well
      as OPG and RANK-L; qualitative measurements will be performed by infra-red diagnosis.

      Aim 3- To determine the initial bone stability of dental implants placed in diabetic
      patients.

      Approach: Statistical analysis will correlate all data from many time points regarding the
      cytokine levels from implants and teeth (PICF/GCF respectively) and from all patients
      (diabetics and non diabetics) to verify the impact of host response on inflammation and bone
      stability over time.
    

Intervention name(s): Implant placement; Implants surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): dental implant placement; dental implant surgery
Other intervention name(s): Dental implants; diabetes patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; implants; cytokines