Apico-coronal Position of the Implant in Edentulous Diabetics With Implant-retained Overdentures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-01

Study Completion Date

2018-10-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus Dental Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This study was designed as a prospective, split-mouth, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Implant placed at supra crestal level (SL)

Implants were placed at supra crestal level (SL)

Group Type EXPERIMENTAL

Dental Implant Placement and subsequent prosthetic reabilithation

Intervention Type DEVICE

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.

Implant placed at crestal level (CL).

Implants were placed at crestal level (CL)

Group Type OTHER

Dental Implant Placement and subsequent prosthetic reabilithation

Intervention Type DEVICE

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.

Interventions

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Dental Implant Placement and subsequent prosthetic reabilithation

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

59 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No