Back to resultsApico-coronal Position of the Implant in Edentulous Diabetics With Implant-retained Overdentures
Primary Purpose
Diabetes Mellitus, Dental Implants
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dental Implant Placement and subsequent prosthetic reabilithation
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring dental prosthesis, biological markers, dental implants
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria included: patients aged between 50 and 80 years old, 2) totally edentulous in the mandible with previous mandibular dentures for at least 6 months and indicated for rehabilitation with overdenture, 3) patients with diabetes had to have had T2DM, diagnosed by a physician, for at least the past 5 years. Such individuals were either under a dietary regimen and/or were using oral hypoglycaemic agents (metformin or glybenclamin).
Exclusion Criteria:
- Exclusion criteria were: 1) pregnancy, 2) lactation, 3) current smoking or ex-smokers, 4) other systemic conditions that could affect bone metabolism (e.g., immunologic disorders), 5) use of anti-inflammatory, immunosuppressive and anti-resorptive medications, 6) patients that required bone grafts before or concomitantly with implant surgery and 7) a history of previous regenerative procedures in the area designated for implant therapy. Patients with major complications of DM (i.e., cardiovascular and peripheral vascular diseases [ulcers, gangrene, and amputation], neuropathy, and nephropathy) were also excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Implant placed at supra crestal level (SL)
Implant placed at crestal level (CL).
Arm Description
Implants were placed at supra crestal level (SL)
Implants were placed at crestal level (CL)
Outcomes
Primary Outcome Measures
Change from baseline Peri-implant Probing Depth (PPD) at 24 months.
distance from the bottom of the peri-implant pocket (PPD) to the mucosal margin (MM) measured by a calibrated examiner in millimeter using a Periodontal probing
Secondary Outcome Measures
Mucosal Margin (MM)
distance from the implant platform to the peri-implant margin (CL group) and distance from the machined collar maintained supracrestally to the peri-implant margin (SL group) measured by a calibrated examiner in millimeter using a Periodontal probing
Clinical attachment level (CAL)
calculated by adding PPD and MM measured by a calibrated examiner in millimeter using a Periodontal probing
Modified Bleeding on Probing
dichotomous index of bleeding during probing around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.
Modified Plaque Index
dichotomous modified plaque index along the mucosal margin around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.
Crest Height Bone Marginal Peri-implant
linear measurement in millimeter obtained by a parallel line to the implant surface from the implant platform to bone crestal (mesial, distal, buccal and lingually) in the sagittal and coronal slices each 2 mm using Cone Beam Computed Tomography (CBCT) scans
Markers on peri-implant crevicular fluid
The levels of Imunoinflammatory mediators: interferon (IFN)-gama, interleukin (IL)-10, IL-17, IL-33, IL-21, IL-4, IL-23, IL-6 and tumor necrosis factor (TNF)-α in the peri-implant crevicular fluid were determined using human plex and the multiplexing instrument. The mean concentration of each biomarker was calculated and expressed as pg/ml.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03988140
Brief Title
Apico-coronal Position of the Implant in Edentulous Diabetics With Implant-retained Overdentures
Official Title
Could the Apico-coronal Position of the Implant Influence the Peri-implant Parameters in Mandibular Edentulous Type 2 Diabetics Rehabilitated With Implant-retained Overdentures? A Split-mouth RCT With 24-months Follow up.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paulista University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diabetes Mellitus (DM) is a recognized factor affecting implant complication rates, including peri-implantitis and peri-implant bone loss, and the apico-coronal position of implants seems interfere on the conditions of peri-implant tissues. However, the influence of the vertical implant position in type 2 diabetics (T2DM) is unclear. This split-mouth randomized controlled trial evaluated the impact of implants of machined-collar placed at crestal level or supracrestally in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.
Detailed Description
Considering the outcomes achieved with implants with machined-collar inserted supracrestally, it would be relevant to investigate whether this therapeutic strategy could be considered as a more effective approach in the rehabilitation with dental implants of individuals with type 2 DM, since these patients may be more disposed to peri-implant changes, both from the point of view of marginal bone remodeling as related to local variations in immunoinflammatory response. Thus, the propose of this split-mouth randomized controlled trial was to compare the impact of crestal level or supracrestally implant platform in T2DM rehabilitated with implant-retained overdentures on the clinical, tomographic and immunoinflammatory peri-implant outcomes after implant loading.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Dental Implants
Keywords
dental prosthesis, biological markers, dental implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study was designed as a prospective, split-mouth, randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implant placed at supra crestal level (SL)
Arm Type
Experimental
Arm Description
Implants were placed at supra crestal level (SL)
Arm Title
Implant placed at crestal level (CL).
Arm Type
Other
Arm Description
Implants were placed at crestal level (CL)
Intervention Type
Device
Intervention Name(s)
Dental Implant Placement and subsequent prosthetic reabilithation
Intervention Description
Surgeries to dental implant placement were performed. All patients received 3.5 mm diameter dental implants - surface blasted with TiO2 particles and machined collar of 1mm - in the interforaminal region of the mandible. The surgical sequence followed the protocol described by the implant company.A two stages protocol was used and the prostheses were placed at 4 months.The prosthetic retention system used in rehabilitation with overdentures was the O'ring and the capture of this component was done directly in the patient's mouth. After 7 and 14 days, the patients returned to occlusal adjustments and verification of prosthetic adaptation. The prostheses were made entirely of acrylic resin without metallic reinforcement and the antagonist of the patients were total edentulous and rehabilitated with muco-supported prostheses.
Primary Outcome Measure Information:
Title
Change from baseline Peri-implant Probing Depth (PPD) at 24 months.
Description
distance from the bottom of the peri-implant pocket (PPD) to the mucosal margin (MM) measured by a calibrated examiner in millimeter using a Periodontal probing
Time Frame
(baseline) and at 6, 12 and 24 months
Secondary Outcome Measure Information:
Title
Mucosal Margin (MM)
Description
distance from the implant platform to the peri-implant margin (CL group) and distance from the machined collar maintained supracrestally to the peri-implant margin (SL group) measured by a calibrated examiner in millimeter using a Periodontal probing
Time Frame
(baseline) and at 6, 12 and 24 months
Title
Clinical attachment level (CAL)
Description
calculated by adding PPD and MM measured by a calibrated examiner in millimeter using a Periodontal probing
Time Frame
(baseline) and at 6, 12 and 24 months
Title
Modified Bleeding on Probing
Description
dichotomous index of bleeding during probing around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.
Time Frame
(baseline) and at 6, 12 and 24 months
Title
Modified Plaque Index
Description
dichotomous modified plaque index along the mucosal margin around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.
Time Frame
(baseline) and at 6, 12 and 24 months
Title
Crest Height Bone Marginal Peri-implant
Description
linear measurement in millimeter obtained by a parallel line to the implant surface from the implant platform to bone crestal (mesial, distal, buccal and lingually) in the sagittal and coronal slices each 2 mm using Cone Beam Computed Tomography (CBCT) scans
Time Frame
(baseline) and at 6, 12 and 24 months
Title
Markers on peri-implant crevicular fluid
Description
The levels of Imunoinflammatory mediators: interferon (IFN)-gama, interleukin (IL)-10, IL-17, IL-33, IL-21, IL-4, IL-23, IL-6 and tumor necrosis factor (TNF)-α in the peri-implant crevicular fluid were determined using human plex and the multiplexing instrument. The mean concentration of each biomarker was calculated and expressed as pg/ml.
Time Frame
(baseline) and at 6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
59 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria included: patients aged between 50 and 80 years old, 2) totally edentulous in the mandible with previous mandibular dentures for at least 6 months and indicated for rehabilitation with overdenture, 3) patients with diabetes had to have had T2DM, diagnosed by a physician, for at least the past 5 years. Such individuals were either under a dietary regimen and/or were using oral hypoglycaemic agents (metformin or glybenclamin).
Exclusion Criteria:
Exclusion criteria were: 1) pregnancy, 2) lactation, 3) current smoking or ex-smokers, 4) other systemic conditions that could affect bone metabolism (e.g., immunologic disorders), 5) use of anti-inflammatory, immunosuppressive and anti-resorptive medications, 6) patients that required bone grafts before or concomitantly with implant surgery and 7) a history of previous regenerative procedures in the area designated for implant therapy. Patients with major complications of DM (i.e., cardiovascular and peripheral vascular diseases [ulcers, gangrene, and amputation], neuropathy, and nephropathy) were also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Conte
Organizational Affiliation
Paulista U
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Ogurtsova K, da Rocha Fernandes JD, Huang Y, et al. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017; 128:40-50. GBD 2016 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet, 390: 1260-1344. Kapur KK, Garrett NR, Hamada MO, et al. A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part I: Methodology and clinical outcomes. J Prosthet Dent. 1998; 79: 555-569.
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Apico-coronal Position of the Implant in Edentulous Diabetics With Implant-retained Overdentures
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