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Soft Tissue Response to Peek and Ti Healing Abutments

NCT04436939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-06-24

No results posted yet for this study

Summary

Introduction: Single-stage dental implant placement protocol involves the placement of healing abutments. In addition to osseointegration process, healing of peri-implant soft tissues is of a great importance too. Routinely, healing abutments made of titanium (Ti) are used. The aim is to find novel materials that would have the same mechanical properties, but less prone to plaque-adhesion and therefore showing lower local inflammatory soft tissue response. Polyetheretherketone (PEEK) is a thermoplastic polymer that has favorable mechanical characteristics, high biocompatibility and low submissiveness to microorganism adhesion. White color makes it aesthetically acceptable in the treatment of patients with thin gingival phenotype.

The Aim: To compare the formation of dental plaque on PEEK and Ti healing abutments and examine the local response of peri-implant tissues.

Materials and Methods: The study included 11 patients with at least two missing teeth in the posterior regions. In each patient, 2 implants were installed, with PEEK abutment (experimental group) placed on one implant, while on the other implant, Ti abutment (control group) was placed. Before prosthetic rehabilitation of patients, both abutments were replaced with new ones and a thin layer of peri-implant soft tissue was sent to histological analysis.

Results: The average age of patients was 49 years. Out of 11 patients, 27% were female and 73% male. 36% of respondents were smokers. Histological immunohistochemical analysis of samples of peri-implant soft tissues showed massive inflammatory infiltration in subepithelial tissue in the experimental group (10/11), while the inflammatory infiltrate in the control group was classified as moderate (7/11) or weak (4/11).

Conclusion: Both types of healing abutments have been shown to be successful in single-stage implantation protocol. However, contrary to expectations and preliminary findings from the literature, PEEK healing abutments showed a more pronounced inflammatory response of the surrounding soft tissues relative to Titanium abutments.

Conditions

  • Dental Implants

Interventions

DEVICE

Dental implant

Following dental implant installation, PEEK or Ti healing abutments were placed according to the split mouth study design.

Sponsors & Collaborators

  • University of Belgrade

    lead OTHER

Principal Investigators

  • Zoran M Aleksic, DDS, MS, PhD · Department of Periodontology, Belgrade School of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-12-03
Completion
2019-02-12

Countries

  • Serbia

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 NCT04436939 on ClinicalTrials.gov