Comparative Study of Implant Surfaces to Enhance Stabilization in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Institut Straumann AG
Information provided by (Responsible Party):
Thomas Oates, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01142297
First received: April 29, 2010
Last updated: December 15, 2014
Last verified: December 2014
  Purpose

This study compares the patterns of dental implant stabilization between a standard and chemically modified implant surface in patients with type 2 diabetes. It is hypothesized that the chemically modified surface will enhance early healing events (first 4 months following placement)in diabetes patients with compromises in rate of implant integration.


Condition Intervention Phase
Partially Edentulous Mandible
Type 2 Diabetes
Device: dental implant and modified dental implant
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial Comparing the Stability of SLA Implants and SLActive Implants Using Resonance Frequency Analysis for Patients With Type 2 Diabetes Mellitus

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Implant Stability Quotient (ISQ) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.


Secondary Outcome Measures:
  • Clinical Success of Implants [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dental implant
standard SLA surface and chemically modified surface
Device: dental implant and modified dental implant
standard SLA surface and chemically modified surface

Detailed Description:

This is a prospective randomized study design whereby type 2 diabetic patients will receive 2 implants in the mandible or maxilla to assess implant integration. One implant will be a regular SLA implant; the other will have a SLActive surface. The primary objective of this randomized controlled study is to evaluate the stability of Straumann 4.1 mm diameter implants in the posterior mandible or maxilla of type 2 diabetic patients during the first 12 weeks after implantation using resonance frequency analysis. The control implant is a standard Straumann implant with an SLA® surface and the test implant the same implant design with SLActive® surface. Assessments will utilize resonance frequency analysis (RFA), as a measure of implant integration, and clinical outcomes of implant success. This study will enroll type 2 diabetes patients having glycated hemoglobin (HbA1c) levels from 8.0% to 12% at baseline.

The primary objective is to test for statistically significant differences in ISQ values between the test and control implants at 2, 3, 4, 6, 7, 8 weeks and 3 months after surgery. If a difference of 2 Osstell RFA ISQ units is detected at any time point it will be considered that the implant having achieved the higher value is better osseointegrated. This split-mouth study design will assess changes in implant stability from baseline as the primary outcome at the implant level. This study will require 20 patients to detect this difference (SD=2.0 ISQ units) with a power of 80% at the P=0.05 level.

Secondary objectives include:

  • Implant survival and implant success at 1-year post loading.
  • The nature and frequency of adverse events/complications between the 2 groups will be compared.
  • Prosthesis success
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females must be at least 18 years of age, and having a diagnosis of type 2 diabetes mellitus occurring over 1 year prior to enrollment (self-reported and verified with physician report, test results, and/or treatment record)
  • Type 2 diabetic patients may be on a modified diet, oral medication, insulin, or combination therapies
  • Glycated hemoglobin A1c (HbA1c) levels of at least 8.0% up to and including 12.0% as reported within 4 weeks of implant placement
  • Have at least two missing teeth in the posterior mandible in FDI positions 4, 5, 6, or 7
  • The tooth at the implant site must have been extracted or lost at least 4 months before the date of implantation
  • Adequate bone quantity at the implant site to permit the insertion of a Straumann Standard or Standard Plus 4.1 mm diameter implant at least 8 mm in length without the use of concurrent bone augmentation techniques, i.e. Implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm lingual and buccal bone will remain
  • Patients must have signed the informed consent form. They must be committed to the study. If the treating clinicians doubt that the patient is willing or will be able to attend all study follow-up visits then the patient should not be admitted to the study

Exclusion Criteria:

  • Patients with a history of systemic disease other than type 2 diabetes mellitus that may preclude dental implant therapy (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders)
  • Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
  • Diabetic retinopathy requiring imminent or planned surgical intervention
  • Diabetic neuropathy of sufficient severity as to require treatment for control of symptoms
  • Serum creatinine > 1.6 mg/dl
  • AST (SGOT) or ALT (AGPT) > 2 times upper limit of normal laboratory range
  • Hypertension, with or without medications, having a systolic pressure > 185mm Hg or diastolic pressure > 105mm Hg
  • Patient has significant untreated oral infections or inflammatory lesions
  • Medical conditions requiring prolonged use of steroids
  • History of leukocyte dysfunction and deficiencies
  • History of bleeding disorders
  • Patients with history of renal failure
  • Patients with metabolic bone disorders
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene
  • Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0
  • Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability

Local Factors:

  • Signs of oral inflammation, such as untreated periodontitis around the teeth or erosive lichen planus in the non-tooth associated areas
  • History of head/neck irradiation therapy
  • Presence of bone defects in the jaw preventing implant placement
  • Unhealed extraction sites (less than 4 months post extraction of teeth in intended sites)
  • Bone surgery (bone grafts, guided tissue regeneration technique for bone enhancement) less than 6 months prior to implant placement
  • Patients requiring bone grafting at the surgical sites at the time of surgery
  • Severe teeth grinding or clenching habits
  • Persistent intraoral infection
  • Lack of sufficient stability of the implant at surgery to allow for proper healing.
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142297

Locations
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Institut Straumann AG
Investigators
Principal Investigator: thomas w oates, dmd, phd University of Texas
  More Information

No publications provided

Responsible Party: Thomas Oates, Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01142297     History of Changes
Other Study ID Numbers: 08-0156H
Study First Received: April 29, 2010
Results First Received: October 27, 2014
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
dental implant
implant stabilization
type 2 diabetes
glycated hemoglobin 8.0-12.0%

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on March 31, 2015