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Influence of Implant Component Materials on Peri-implant Soft Tissue Horst Response.

NCT05843526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-05-06

No results posted yet for this study

Summary

The aim of this study was to characterize the host-related response of peri-implant soft tissue induced by 3 different materials: titanium, resin and PEEK (polyetheretherketone) on man.

The primary endpoint is to asses the histological data available: Histological analyses are carried out with immunohistology (CD68, CD3, CD20, macrophages), non decalcified histology to appreciate the structure of the peri implant soft tissues (Sulcus depth, junctional epithelium, connective tissue adhesion).

Moreover: scanning electronic microscope (SEM) of the experimental abutment is performed to juge the cell adhesion on the abutment surface.

The secondary endpoint is to assess clinical data, radiological bone remodeling regarding the different material.

The hypothesis is that resin abutment lead to more inflammation than PEEK or titanium.

Conditions

  • Dental Implants
  • Soft Tissue Inflammation
  • Immunohistochemistry
  • Dental Implants, Single-Tooth
  • Histology
  • Dental Implantation

Interventions

DEVICE

Experimental healing abutment

Implant placement (Straumann) Experimental abutment made of titanium, PEEK polyetheretherketone, resin was randomly assessed to the implant site. Abutment screw channel was filled with Teflon and closed with resin composite. Mouthwash based 0.2% chlorhexidine for 10 days and analgesics (ibuprofen 400 mg, up to 4/d) if necessary. After 8 weeks, harvesting of the soft tissues around experimental abutment with experimental abutment using a custom-made guide was placed on the experimental abutment

Sponsors & Collaborators

  • ITI International Team for Implantology, Switzerland

    collaborator OTHER

  • University of Liege

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-05-01
Completion
2022-10-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843526 on ClinicalTrials.gov