Influence of Implant Component Materials on Peri-implant Soft Tissue Horst Response.
NCT ID: NCT05843526
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2019-05-01
2022-10-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Titanium abutment
Titanium (Ti) grade 5 titanium abutment
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
Dental resin abutment
Dental resin (Re) Optibond ™ FL, Kerr Dental abutment
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
Polyetheretherketone abutment
Polyetheretherketone (PEEK) Polyetheretherketone abutment
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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ITI International Team for Implantology, Switzerland
OTHER
University of Liege
OTHER
Responsible Party
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Dr. France LAMBERT
Professor
Locations
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Hospital University of Liège (CHU-Ulg)
Liège, , Belgium
Countries
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Other Identifiers
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B707201628072
Identifier Type: -
Identifier Source: org_study_id
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