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

NCT03988140 | Completed

• 1 other identifier: apico-coronal position
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Dental Implants

Keywords

dental prosthesis; biological markers; dental implants

Outcome Measures

Primary Outcomes (1)

• 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

  (baseline) and at 6, 12 and 24 months

Secondary Outcomes (6)

• Mucosal Margin (MM)

  (baseline) and at 6, 12 and 24 months

• Clinical attachment level (CAL)

  (baseline) and at 6, 12 and 24 months

• Modified Bleeding on Probing

  (baseline) and at 6, 12 and 24 months

• Modified Plaque Index

  (baseline) and at 6, 12 and 24 months

• Crest Height Bone Marginal Peri-implant

  (baseline) and at 6, 12 and 24 months

Study Arms (2)

Implant placed at supra crestal level (SL)

EXPERIMENTAL

Implants were placed at supra crestal level (SL)

Device: Dental Implant Placement and subsequent prosthetic reabilithation

Implant placed at crestal level (CL).

OTHER

Implants were placed at crestal level (CL)

Device: Dental Implant Placement and subsequent prosthetic reabilithation

Interventions

Dental Implant Placement and subsequent prosthetic reabilithation 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).; Implant placed at supra crestal level (SL)

Eligibility Criteria

• Age: 59 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Paulista University: lead

Related Publications (2)

• 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.

  BACKGROUND

• Conte A, Ghiraldini B, Denofrio PHF, Marcello-Machado RM, Correa MG, Pimentel SP, Casati MZ, Pecorari VGA, Cirano FR. Supracrestal implant placement improves peri-implant health in T2DM patients: A randomized clinical trial. J Dent. 2025 Oct;161:106002. doi: 10.1016/j.jdent.2025.106002. Epub 2025 Jul 25.

  PMID: 40716558 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alexandre Conte

  Paulista U

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 17, 2019
• Study Start: November 1, 2014
• Primary Completion: September 12, 2018
• Study Completion: October 29, 2018
• Last Updated: June 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share