NCT04630691

Brief Summary

The aim of the present study was to compare the initial healing and long term performance of narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and healthy individuals.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

4 years

First QC Date

November 13, 2020

Last Update Submit

November 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • No difference

    3 months

Study Arms (2)

Control

Patients with HbA1c around 6,0

Procedure: Implantation

T2DM

Patients with HbA1c above 6,5

Procedure: Implantation

Interventions

ImplantationPROCEDURE

Patients received narrow diameter implants in posterior mandible or maxilla

ControlT2DM

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All

You may qualify if:

  • Patients with one or more missing teeth posterior to the canine either in the maxilla or mandible and associated with diminished alveolar ridge dimensions were included in the study

You may not qualify if:

  • immobility of diabetic patients
  • periodontal surgery and/or antibiotic therapy within the last 6 months prior to baseline
  • pregnancy and lactation period
  • Full Mouth Plaque Score (FMPS) \> 25%
  • untreated periodontitis
  • smoking \> 10 cigarettes/day
  • insufficient crestal volume making an augmentation procedure necessary
  • previously performed ridge augmentation procedure for a staged implant placement
  • permanent medication potentially affecting blood perfusion rate and bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Diehl D, Bespalov A, Yildiz MS, Friedmann A. Restoration of posterior teeth by narrow diameter implants in hyperglycemic and normoglycemic patients - 4-year results of a case-control study. Clin Oral Investig. 2024 Jun 22;28(7):392. doi: 10.1007/s00784-024-05786-0.

  • Diehl D, Kaner D, Bockholt A, Bilhan H, Friedmann A. Microcirculation and neutrophil-related cytokine concentrations are not altered around narrow diameter implants in T2DM patients during wound healing. Clin Oral Investig. 2023 Mar;27(3):1167-1175. doi: 10.1007/s00784-022-04731-3. Epub 2022 Oct 13.

  • Friedmann A, Winkler M, Diehl D, Yildiz MS, Bilhan H. One-year performance of posterior narrow diameter implants in hyperglycemic and normo-glycemic patients-a pilot study. Clin Oral Investig. 2021 Dec;25(12):6707-6715. doi: 10.1007/s00784-021-03957-x. Epub 2021 May 3.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 16, 2020

Study Start

December 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share