Clinical trial NCT03988140: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Dental Implants
Keywords: dental prosthesis
biological markers
dental implants
Lead sponsor: Paulista University
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 22
Sex: ALL
Minimum age (years): 59
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study was designed as a prospective, split-mouth, randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline Peri-implant Probing Depth (PPD) at 24 months.
timeFrame: (baseline) and at 6, 12 and 24 months
Secondary outcomes:
measure: Mucosal Margin (MM)
timeFrame: (baseline) and at 6, 12 and 24 months
measure: Clinical attachment level (CAL)
timeFrame: (baseline) and at 6, 12 and 24 months
measure: Modified Bleeding on Probing
timeFrame: (baseline) and at 6, 12 and 24 months
measure: Modified Plaque Index
timeFrame: (baseline) and at 6, 12 and 24 months
measure: Crest Height Bone Marginal Peri-implant
timeFrame: (baseline) and at 6, 12 and 24 months
measure: Markers on peri-implant crevicular fluid
timeFrame: (baseline) and at 6, 12 and 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Paulista U
name: Alexandre Conte
role: STUDY_CHAIR
References:
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.