Healing Profile of Titanium Dental Implants Placed in Patients With Diabetes

May 5, 2012 updated by: Getulio Nogueira, Escola Bahiana de Medicina e Saude Publica

Healing Profile of Titanium Dental Implants Placed in Patients With Type 2 Diabetes: a Prospective Osteoimmunological and Clinical Pilot Study

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Type 2 diabetes patients and with partial edentulism.

Exclusion Criteria:

  • Active periodontal disease,
  • Uncontrolled diabetes,
  • Smokers,
  • Any metabolic bone diseases or other systemic disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetes
compare cytokines between diabetes and non diabetes patients
Procedure: Implants surgery
dental implant surgery
Other Names:
  • diabetes patients
Active Comparator: Implants
Compare implant healing phases
Procedure: Implants surgery
dental implant surgery
Other Names:
  • diabetes patients
Procedure: Implant placement
dental implant placement
Other Names:
  • Dental implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Healing profile of cytokines
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escola Bahiana de Medicina e Saude Publica

Collaborators

University of Manitoba
University of Toronto

Investigators

  • Principal Investigator: Getulio R Nogueira F, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 5, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPL900209-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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