Soft Tissue Response to Peek and Ti Healing Abutments

NCT04436939 | Completed

• 1 other identifier: 22101980.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dental implant; healing abutment; PEEK; Titanium

Outcome Measures

Primary Outcomes (1)

• Soft tissue inflammatory reaction around healing abutments

  For microscopic histological evaluation, soft tissue biopsies were prepared, dyed with a haematoxylin-eosin stain and analyzed by light microscopy for presence, localization and intensity of the inflammation.

  Three month after the implant placement

Study Arms (2)

PEEK healing abutment

EXPERIMENTAL

Healing abutment made of polyetheretherketone (PEEK)

Device: Dental implant

Ti healing abutment

ACTIVE COMPARATOR

Healing abutment made of titanium (Ti)

Device: Dental implant

Interventions

Dental implant DEVICE

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

PEEK healing abutment; Ti healing abutment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with partial edentulism in posterior maxillary or mandibular arches, with missing at least two teeth that were extracted at least 6 months earlier
• Adequate bone quantity at the experimental sites to allow the insertion of 3.8 or 4.3 mm diameter implants
• Sufficient band of keratinized mucosa at the experimental sites

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

Department of Periodontology, School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (1)

• Milinkovic I, Krasavcevic AD, Jankovic S, Sopta J, Aleksic Z. Immunohistochemical analysis of soft tissue response to polyetheretherketone (PEEK) and titanium healing abutments on dental implants: a randomized pilot clinical study. BMC Oral Health. 2022 Nov 11;22(1):484. doi: 10.1186/s12903-022-02536-0.

  PMID: 36368972 DERIVED

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Zoran M Aleksic, DDS, MS, PhD

  Department of Periodontology, Belgrade School of Dental Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This was a split mouth study design in which both test and control group were the same patient

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: June 1, 2018
• Primary Completion: December 3, 2018
• Study Completion: February 12, 2019
• Last Updated: June 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)