NCT05843526

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Implants
• Soft Tissue Inflammation
• Immunohistochemistry
• Dental Implants, Single-Tooth
• Histology
• Dental Implantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-05-01
• Completion: 2022-10-01
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: Belgium