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Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients

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ClinicalTrials.gov Identifier: NCT04630691
Recruitment Status : Completed
First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
Institut Straumann AG
Information provided by (Responsible Party):
University of Witten/Herdecke

Study Description
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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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Implant Complication Procedure: Implantation

Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients
Actual Study Start Date : December 1, 2012
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
Control
Patients with HbA1c around 6,0
 Procedure: Implantation
Patients received narrow diameter implants in posterior mandible or maxilla
T2DM
Patients with HbA1c above 6,5
 Procedure: Implantation
Patients received narrow diameter implants in posterior mandible or maxilla


Outcome Measures
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Primary Outcome Measures :
  1. No difference [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Witten/Herdecke
ClinicalTrials.gov Identifier: NCT04630691    
Other Study ID Numbers: UWHPerioT2DM
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases