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

NCT01142297 | Completed Results

• 1 other identifier: 08-0156H
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partially Edentulous Mandible; Type 2 Diabetes

Keywords

dental implant; implant stabilization; type 2 diabetes; glycated hemoglobin 8.0-12.0%

Outcome Measures

Primary Outcomes (1)

• Implant Stability Quotient (ISQ)

  resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.

  4 months

Secondary Outcomes (1)

• Clinical Success of Implants

  1 year

Study Arms (1)

dental implant

OTHER

standard SLA surface and chemically modified surface

Device: dental implant and modified dental implant

Interventions

dental implant and modified dental implant DEVICE

standard SLA surface and chemically modified surface

dental implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Institut Straumann AG: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Thomas W. Oates
• Organization: University of Texas Health Science Center at San Antonio

oates@uthscsa.edu

210-567-3590

Study Officials

• thomas w oates, dmd, phd

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: June 11, 2010
• Study Start: July 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 3, 2018
• Results First Posted: December 22, 2014

Record last verified: 2016-09

Locations

US (1)