NCT00971516

Brief 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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

September 2, 2009

Last Update Submit

May 5, 2012

Conditions

Type 2 DiabetesDental Implants

Keywords

diabetesimplantscytokines

Outcome Measures

Primary Outcomes (1)

  • Healing profile of cytokines

    1 year

Study Arms (2)

Diabetes

ACTIVE COMPARATOR

compare cytokines between diabetes and non diabetes patients

Procedure: Implants surgery

Implants

ACTIVE COMPARATOR

Compare implant healing phases

Procedure: Implant placementProcedure: Implants surgery

Interventions

Implant placementPROCEDURE

dental implant placement

Also known as: Dental implants
Implants
Implants surgeryPROCEDURE

dental implant surgery

Also known as: diabetes patients
DiabetesImplants

Eligibility Criteria

Age35 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes patients and with partial edentulism.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Getulio R Nogueira F

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

May 1, 2012

Last Updated

May 8, 2012

Record last verified: 2012-05