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: July 18, 2012
Last verified: July 2012
  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
Device: modified dental implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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

Resource links provided by NLM:


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


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
Active Comparator: dental implant
standard SLA surface
Device: dental implant
standard SLA surface
Experimental: modified dental implant
chemically modified surface
Device: modified dental implant
chemically modified surface

  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
Last Updated: July 18, 2012
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
Diabetes Mellitus, Type 2
Mouth, Edentulous
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on August 28, 2014