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Analysis of implants with different designs over 10 years of follow-up

Analysis of the microbiome and proteomics of peri-implant crevicular fluid associated with healthy and peri-implantitis-affected implants, comparing different implant designs - A randomized, controlled, double-blind trial in a split-mouth model with 10-year follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10s8qxy8
Enrollment
Unknown
Registered
2025-12-22
Start date
2012-02-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth loss

Interventions

This evaluation proposal is part of a prospective, randomized, controlled, double-blind, split-mouth clinical trial, aimed primarily at assessing clinical, biological, bacteriological, and biomechanic
crestal modules with and without threads (nTh)
crestal module with and without surface treatment (wT) (STUDY 1: different designs of crestal module)
and different levels of implant-abutment platform diameter mismatch (Platform Switching): implants with external hexagon of Ø 4.5 x 13 mm and abutment diameter of 4.5 mm (conventional implant-abutment

Sponsors

Associação Salgado de Oliveira de Educação e Cultura
Lead Sponsor
Centro Universitário do Triângulo
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Clinically healthy patients; Both genders; Age between 18 to 70; Completely edentulous patients; Dental extractions performed more than 6 months previously

Exclusion criteria

Exclusion criteria: Patients with alcohol, drug or medication abuse; Smokers or those with systemic diseases, such as uncontrolled diabetes; Coagulation disorders; Severe cardiac vascular disorders and other significant illnesses

Design outcomes

Primary

MeasureTime frame
In this study, two comparisons were performed. In study 1, external hexagonal (EH) and Morse taper (MT) connections were compared; crestal modules with and without thread (nTh); crest modulus with and without surface treatment (wT). In study 2, different differences in diameter of the implant-abutment platform (Switching Platform) were evaluated: implants with an external hexagon of Ø 4.5 x 13 mm and an abutment diameter of 4.5 mm (conventional compatible implant-abutment design - CMD), 4.1mm (PS04), 3.8mm (PS07) and 3.3 (PS12). 24 patients underwent surgery, 12 in each group, who received one type of each implant configuration. The primary variable of this study was the peri-implant bone level, and one connection will be considered superior to another when the difference in this parameter was greater than 1 mm.

Secondary

MeasureTime frame
Microbiome and proteomic analysis will describe whether clinical differences are related to differences in microbiological composition and expression of inflammatory markers. Connections with less bone loss are expected to present lower expression of biological mediators of inflammation and a lower presence of anaerobic gram-negative bacteria.

Countries

Brazil

Contacts

Public ContactRoberto Pessoa

Centro Universitário do Triângulo - UNITRI

rp@inpes.com.br+55 (34) 4009-9000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)