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

Sponsor

University of Liege (Other)

Overall Status

Completed

CT.gov ID

NCT05843526

Collaborator

ITI International Team for Implantology, Switzerland (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Implants Soft Tissue Inflammation Immunohistochemistry Dental Implants, Single-Tooth Histology Dental Implantation	Device: Experimental healing abutment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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

Primary Purpose:

Prevention

Official Title:

Influence of Implant Component Materials on Peri-implant Soft Tissue Host-response: A Randomized Clinical Trial.

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Titanium abutment Titanium (Ti) grade 5 titanium abutment	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
Experimental: Dental resin abutment Dental resin (Re) Optibond ™ FL, Kerr Dental abutment	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
Experimental: Polyetheretherketone abutment Polyetheretherketone (PEEK) Polyetheretherketone abutment	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

Arm

Intervention/Treatment

Active Comparator: Titanium abutment

Titanium (Ti) grade 5 titanium abutment

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

Experimental: Dental resin abutment

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

Device: Experimental healing abutment

Experimental: Polyetheretherketone abutment

Polyetheretherketone (PEEK) Polyetheretherketone abutment

Device: Experimental healing abutment

Outcome Measures

Primary Outcome Measures

Soft tissue inflammatory response [8 weeks]
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 [8 weeks]
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 [8 weeks]
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 [8 weeks]
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 [8 weeks]
Assessment of plaque percentage
Soft tissue health changes assessed by Keratinized gingiva measure [8 weeks]
Assessment of height of keratinized mucosa by probing in mm.
Soft tissue health changes assessed by soft tissues height [8 weeks]
Assessment of height of soft tissue by probing in mm.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.