Partially Edentulous MandibleNCT01142297
Comparative Study of Implant Surfaces to Enhance Stabilization in Patients With Type 2 Diabetes
A study testing dental implant and modified dental implant in people with Partially Edentulous Mandible and Type 2 Diabetes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partially Edentulous Mandible, Type 2 Diabetes
- What is being tested?
- dental implant and modified dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
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
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.
Read the 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
- Conditions
- Partially Edentulous Mandible, Type 2 Diabetes
- Being tested
- dental implant and modified dental implant
- Keywords
- dental implant, implant stabilization, type 2 diabetes, glycated hemoglobin 8.0-12.0%
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant and modified dental implantDevice
standard SLA surface and chemically modified surface
| Study group | Role | What they receive |
|---|---|---|
| dental implant | Other | standard SLA surface and chemically modified surface Receives: Device: dental implant and modified dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
Clinical Success of Implants
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partially Edentulous MandibleStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Sponsor
- Investigators
- thomas w oates, dmd, phd, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142297
- Sponsor's protocol ID
- 08-0156H
- Status last verified
- Sep 2016
- First submitted
- 29 Apr 2010
- Last updated
- 3 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01142297
- Acronym / sponsor ID
- 08-0156H
- Conditions
- Partially Edentulous Mandible, Type 2 Diabetes
- Keywords
- dental implant, implant stabilization, type 2 diabetes, glycated hemoglobin 8.0-12.0%
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- Jul 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Posted 22 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dental implant | Other | Device: dental implant and modified dental implantstandard SLA surface and chemically modified surface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implant and modified dental implantstandard SLA surface and chemically modified surface | Device | dental implant |
Primary outcome
Implant Stability Quotient (ISQ)
Time frame: 4 months
resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.
1 secondary outcome
Clinical Success of Implants
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Partially Edentulous Mandible
Active, not recruiting
Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Partially Edentulous Maxilla or Mandible
Not yet recruiting
Evaluation of Occlusal Contact Distribution in Digitally Fabricated Implant-Retained Fixed Partial Dentures in Mandibular Kennedy Class II Patients Following Artificial Intelligence Bite Optimization: A Quasi-Experimental Study
Partially Edentulous Mandible
RecruitingPhase 4
Artificial Intelligence Assisted Workflow Versus Conventional Workflow in Guided Implant Placement
Partially Edentulous Mandible
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
Active, not recruiting
Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.
Completely Edentulous, Implant Assesment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
thomas w oates, dmd, phd principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant and modified dental implant in people with Partially Edentulous Mandible and Type 2 Diabetes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability Quotient (ISQ) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.