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NCT04630691 Clinical Trial

Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Evaluation of Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04630691
Other study ID # UWHPerioT2DM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2012
Est. completion date December 1, 2017

Study information
Verified date November 2020
Source University of Witten/Herdecke
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date December 1, 2017
Est. primary completion date December 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Implantation
Patients received narrow diameter implants in posterior mandible or maxilla

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Witten/Herdecke Institut Straumann AG

Outcome
Type Measure Description Time frame Safety issue
Primary No difference 3 months
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