NCT03988140

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Paulista University · Academic / Other
• Sex: All
• Age: 59 Years – 77 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Dental Implants

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-09-12
• Completion: 2018-10-29
• First posted: 2019-06-17
• Last updated: 2019-06-17