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

• Sponsor: Paulista University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03988140
• Collaborator: (none)
• Enrollment: 22
• Arms: 2
• Actual Duration (Months): 47.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus; Dental Implants	Device: Dental Implant Placement and subsequent prosthetic reabilithation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: This study was designed as a prospective, split-mouth, randomized controlled trialThis study was designed as a prospective, split-mouth, randomized controlled trial
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Sep 12, 2018
• Actual Study Completion Date: Oct 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implant placed at supra crestal level (SL) Implants were placed at supra crestal level (SL)	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.
Other: Implant placed at crestal level (CL). Implants were placed at crestal level (CL)	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.

Outcome Measures

Primary Outcome Measures

1. Change from baseline Peri-implant Probing Depth (PPD) at 24 months. [(baseline) and at 6, 12 and 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

1. Mucosal Margin (MM) [(baseline) and at 6, 12 and 24 months]

   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

2. Clinical attachment level (CAL) [(baseline) and at 6, 12 and 24 months]

   calculated by adding PPD and MM measured by a calibrated examiner in millimeter using a Periodontal probing

3. Modified Bleeding on Probing [(baseline) and at 6, 12 and 24 months]

   dichotomous index of bleeding during probing around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.

4. Modified Plaque Index [(baseline) and at 6, 12 and 24 months]

   dichotomous modified plaque index along the mucosal margin around implants measured by a calibrated examiner using a Periodontal probing. Data were presented as percentage.

5. Crest Height Bone Marginal Peri-implant [(baseline) and at 6, 12 and 24 months]

   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

6. Markers on peri-implant crevicular fluid [(baseline) and at 6, 12 and 24 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 59 Years to 77 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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,

1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Paulista University

Investigators

• Study Chair: Alexandre Conte, Paulista U

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. 2017 Sep 16;390(10100):1260-1344. doi: 10.1016/S0140-6736(17)32130-X. Erratum in: Lancet. 2017 Oct 28;390(10106):e38.

• Responsible Party: Fernanda Vieira Ribeiro, Principal Investigator, Paulista University
• ClinicalTrials.gov Identifier: NCT03988140
• Other Study ID Numbers: apico-coronal position
• First Posted: Jun 17, 2019
• Last Update Posted: Jun 17, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fernanda Vieira Ribeiro, Principal Investigator, Paulista University: dental prosthesis; biological markers; dental implants
• Additional relevant MeSH terms: Mouth, Edentulous

Study Results

No Results Posted as of Jun 17, 2019