Healing Profile of Titanium Dental Implants Placed in Patients With Diabetes

2014-08-27 03:19:32 | BioPortfolio


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?



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.


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.

Study Design

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Type 2 Diabetes


Implant placement, Implants surgery


Not yet recruiting


Escola Bahiana de Medicina e Saude Publica

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:19:32-0400

Clinical Trials [5355 Associated Clinical Trials listed on BioPortfolio]

Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla

The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal ...

Dynamic Navigation-Assisted Dental Implant Placement

Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic su...

A Non-Interventional Study to Document the Use of Straumann BLX Implants in Daily Dental Practice

Prospective, multi-center, non-interventional observation to document the success and survival rates of Straumann BLX Implants used for tooth replacement in cleared indications up to 1 yea...

Esthetic, Clinical and Radiographic Outcomes of Immediate and Early Implant Placement

The aim of this prospective randomized controlled clinical trial is to compare the esthetic, clinical and patient-centered outcomes following immediate and early implant placement protocol...

Computer Guided Versus Free Hand Immediate Implant Placement

Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediate...

PubMed Articles [20834 Associated PubMed Articles listed on BioPortfolio]

Novel approach for risk-reducing mastectomy - first stage implant placement and subsequent second stage mastectomy.

Risk-reducing mastectomy (RRM) with tissue expander then implant-based breast reconstruction conventionally involved immediate submuscular placement of tissue expanders during mastectomy, then after e...

Methods of removing failed implants.

Implant restoration has become one of the most regular methods of restoring dentition defect or edentulous. Implant placement and osseointegration are partly unreserved (fracture, implant is not in th...

A subperiosteal maxillary implant causing severe osteolysis.

Subperiosteal implant denture therapy was initially introduced in 1942 in Sweden and was then used worldwide for the treatment of fully edentulous maxillary or mandibular arches with advanced bone atr...

The Effect of Moderately Controlled Type 2 Diabetes on Dental Implant Survival and Peri-implant Bone Loss: A Long-Term Retrospective Study.

The objective of this study was to assess whether long-term implant survival rates and bone loss in patients with moderately controlled type 2 diabetes is similar to the rates reported in the nondiabe...

Real vs. virtual position of single implants installed in pre-maxilla via guided surgery: A proof of concept analyzing positional deviations.

The aim of this research letter was to report the results of a pilot study designed to compare the real and virtual position of implants placed using computer-guided flapless implant surgery for singl...

Medical and Biotech [MESH] Definitions

Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.

Endosseous dental implantation where implants are fitted with an abutment or where an implant with a transmucosal coronal portion is used immediately (within 1 week) after the initial extraction. Conventionally, the implantation is performed in two stages with more than two months in between the stages.

Implants used in arthroscopic surgery and other orthopedic procedures to attach soft tissue to bone. One end of a suture is tied to soft tissue and the other end to the implant. The anchors are made of a variety of materials including titanium, stainless steel, or absorbable polymers.

The time period before the development of symptomatic diabetes. For example, certain risk factors can be observed in subjects who subsequently develop INSULIN RESISTANCE as in type 2 diabetes (DIABETES MELLITUS, TYPE 2).

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

More From BioPortfolio on "Healing Profile of Titanium Dental Implants Placed in Patients With Diabetes"

Quick Search


Relevant Topics

Dentistry is the study, management and treatment of diseases and conditions affecting the mouth, jaw, teeth and their supporting tissues (Oxford Medical Dictionary) The work of a dentist ranges from regular patient check-up to orthodontics and surgery....

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial