Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients

NCT ID: NCT04630691

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-01

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Implant Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Patients with HbA1c around 6,0

Implantation

Intervention Type PROCEDURE

Patients received narrow diameter implants in posterior mandible or maxilla

T2DM

Patients with HbA1c above 6,5

Implantation

Intervention Type PROCEDURE

Patients received narrow diameter implants in posterior mandible or maxilla

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantation

Patients received narrow diameter implants in posterior mandible or maxilla

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Straumann AG

INDUSTRY

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38907052 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36229741 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33939006 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UWHPerioT2DM

Identifier Type: -

Identifier Source: org_study_id