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

Primary Purpose

Dental Implants, Soft Tissue Inflammation, Immunohistochemistry

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Experimental healing abutment
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Implants focused on measuring Dental implants, Soft Tissue Inflammation, Abutment materials, Immunohistochemistry, histometry, Peri implant tissues, dental material, Dental abutments, histology, peri implant tissue changes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 3 mm of keratinized mucosa in the bucco-lingual dimension with bone crest allowing at least a regular diameter implant (4.1 mm). Exclusion Criteria: 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.

Sites / Locations

  • Hospital University of Liège (CHU-Ulg)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Titanium abutment

Dental resin abutment

Polyetheretherketone abutment

Arm Description

Titanium (Ti) grade 5 titanium abutment

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

Polyetheretherketone (PEEK) Polyetheretherketone abutment

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

dental plaque accumulation
To assess the amount of plaque present on the abutments with SEM analysis. semi quantitative analyses are performed on the abutment.
Peri-implant bone remodeling
Assessment of bone height changes using X-rays Radiographies are analyzed with software ImageJ and mesial and distal values of the bone remodeling (bone line to the implant shoulder) are collected in mm.
Soft tissue health changes assessed by Plaque Index
Assessment of plaque percentage
Soft tissue health changes assessed by Keratinized gingiva measure
Assessment of height of keratinized mucosa by probing in mm.
Soft tissue health changes assessed by soft tissues height
Assessment of height of soft tissue by probing in mm.

Full Information

First Posted
April 5, 2023
Last Updated
April 24, 2023
Sponsor
University of Liege
Collaborators
ITI International Team for Implantology, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT05843526
Brief Title
Influence of Implant Component Materials on Peri-implant Soft Tissue Horst Response.
Acronym
PISTI
Official Title
Influence of Implant Component Materials on Peri-implant Soft Tissue Host-response: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
Collaborators
ITI International Team for Implantology, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The present study was designed as a randomized controlled trial. A total of 69 implants were placed and experimental abutments made of grade 5 titanium (Ti), dental resin (Optibond ™ FL, Kerr Dental)), polyetheretherketone (PEEK) were randomly allocated to each implant. Study population: Patients needing tooth replacement in the posterior region (molars) are recruited from the Department of Periodontology and Oral and Implant Surgery of the University of Liege, Belgium. Procedures After a local anesthesia, implant procedure is carried out according to the recommendation of the manufacturer while considering the future position of the crown for a screw-retained restoration and the bone anatomy. Then, implants (Bone level or Bone level tapered, SLA active, Straumann Group, Basel, Switzerland) are placed with an insertion torque of at least 20 N/cm. The experimental abutment material is randomly allocated to the implant or two implants when it is possible: Titanium as a group control, PEEK (polyetheretherketone) or resin abutment. The insertion is made at 15 N/cm and the access hole is obturated with teflon and Telio (Ivoclar vivadent, Schaan, Liechtenstein). A standardized parallel peri-apical radiograph is taken in order to record the baseline bone level. Each patient is instructed to rinse twice daily with an aqueous solution of 0,2% Chlorhexidine (Corsodyl®, GSK, Brentford, United Kingdom) and to avoid brushing of the area until the first recall 10-12 days later. Anti-inflammatories (Ibuprofen® 600 mg) as well as additional analgesics (Paracetamol® 500 mg) are recommended according to the patient's needs. Eight weeks after implantation, the buccal part of the abutment is marked with a drill, and a harvesting guide is placed on the experimental abutment. A punch device cut the soft tissue at 1mm from the abutment surface and both soft tissues and abutment are removed together. When the adherence between soft tissues and abutment is weak (soft tissues slide from the abutment), the abutment is analyzed alone on scanning electronic microscopy and the soft tissues alone are analyzed with immunohistochemistry. When adherence between the abutment and the soft tissues is sufficient, it goes to non decalcified histology. A screw retained abutment or a conventional healing abutment is placed after the harvesting procedure and the prosthetic rehabilitation is performed after 3 months of healing. Follow-up evaluations and data recording are performed at inclusion visit (baseline), surgery and 8 weeks after implantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Masking Description
Patient was allocated to a number. The collected samples were assigned to a reference number
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Titanium abutment
Arm Type
Active Comparator
Arm Description
Titanium (Ti) grade 5 titanium abutment
Arm Title
Dental resin abutment
Arm Type
Experimental
Arm Description
Dental resin (Re) Optibond ™ FL, Kerr Dental abutment
Arm Title
Polyetheretherketone abutment
Arm Type
Experimental
Arm Description
Polyetheretherketone (PEEK) Polyetheretherketone abutment
Intervention Type
Device
Intervention Name(s)
Experimental healing abutment
Intervention Description
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
Primary Outcome Measure Information:
Title
Soft tissue inflammatory response
Description
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.
Time Frame
8 weeks
Title
Characterization of peri implant soft tissues
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
dental plaque accumulation
Description
To assess the amount of plaque present on the abutments with SEM analysis. semi quantitative analyses are performed on the abutment.
Time Frame
8 weeks
Title
Peri-implant bone remodeling
Description
Assessment of bone height changes using X-rays Radiographies are analyzed with software ImageJ and mesial and distal values of the bone remodeling (bone line to the implant shoulder) are collected in mm.
Time Frame
8 weeks
Title
Soft tissue health changes assessed by Plaque Index
Description
Assessment of plaque percentage
Time Frame
8 weeks
Title
Soft tissue health changes assessed by Keratinized gingiva measure
Description
Assessment of height of keratinized mucosa by probing in mm.
Time Frame
8 weeks
Title
Soft tissue health changes assessed by soft tissues height
Description
Assessment of height of soft tissue by probing in mm.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 3 mm of keratinized mucosa in the bucco-lingual dimension with bone crest allowing at least a regular diameter implant (4.1 mm). Exclusion Criteria: 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.
Facility Information:
Facility Name
Hospital University of Liège (CHU-Ulg)
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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