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

NCT05843526 | Completed

• 1 other identifier: B707201628072
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental implants; Soft Tissue Inflammation; Abutment materials; Immunohistochemistry; histometry; Peri implant tissues; dental material; Dental abutments; histology; peri implant tissue changes

Outcome Measures

Primary Outcomes (2)

• Soft tissue inflammatory response

  To evaluate the inflammatory response of the peri-implant soft tissue after 8 weeks in contact with the abutment material: Immunohistological analysis of the quantity of macrophages, neutrophils, B and T lymphocytes and blood vessels present in the different samples. It has been evaluated using markers: CD3, CD20, CD68, CD34 and counting of marked cells. Data are reported with semi quantitative scale.

  8 weeks

• Characterization of peri implant soft tissues

  To determine the composition and the length of different parts of the peri implant soft tissues depending on subgingival abutment material (regarding the data of sulcus depth, junctional epithelium and connective tissue in mm) using non decalcified histology.

  8 weeks

Secondary Outcomes (5)

• dental plaque accumulation

  8 weeks

• Peri-implant bone remodeling

  8 weeks

• Soft tissue health changes assessed by Plaque Index

  8 weeks

• Soft tissue health changes assessed by Keratinized gingiva measure

  8 weeks

• Soft tissue health changes assessed by soft tissues height

  8 weeks

Study Arms (3)

Titanium abutment

ACTIVE COMPARATOR

Titanium (Ti) grade 5 titanium abutment

Device: Experimental healing abutment

Dental resin abutment

EXPERIMENTAL

Dental resin (Re) Optibond ™ FL, Kerr Dental abutment

Device: Experimental healing abutment

Polyetheretherketone abutment

EXPERIMENTAL

Polyetheretherketone (PEEK) Polyetheretherketone abutment

Device: Experimental healing abutment

Interventions

Experimental healing abutment DEVICE

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

Dental resin abutment; Polyetheretherketone abutment; Titanium abutment

Eligibility Criteria

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

You may qualify if:

• Needing implant therapy
• One or more missing teeth in the posterior area of either maxilla or mandible
• Good systemic health (ASA I/II)
• Full mouth plaque score (FMPI) lower than or equal to 25%
• The tooth at the implant site(s) had to be extracted or lost at least 12 weeks prior to implant placement
• mm of keratinized mucosa in the bucco-lingual dimension with bone crest allowing at least a regular diameter implant (4.1 mm).

You may not qualify if:

• Autoimmune disease requiring medical treatment
• Medical conditions requiring prolonged use of steroids, use of bisphosphonates and denosumab intravenously or in oral use
• Pregnancy or breastfeeding women
• Alcoholism o chronical drug abuse
• Immunocompromised patients
• Uncontrolled diabetes
• Smokers (more than 5 cigs/day)
• Implant diameter under 4 mm (narrow implant)
• Infection (systemic or local)
• The site was excluded if it was previously treated with socket preservation techniques, presented untreated local inflammation, mucosal diseases or oral lesions, history of local irradiation therapy or persistent intraoral infection.

Sponsors & Collaborators

• University of Liege: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Hospital University of Liège (CHU-Ulg)

Liège, 4000, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patient was allocated to a number. The collected samples were assigned to a reference number
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study included 69 implants divided into 3 groups. The 1st control group with titanium abutments, a second test group on dental resin (Optibond ™ FL, Kerr Dental) and a last test group on polyetheretherketone (PEEK).

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)