Dental Implants Clinical Trial
— PISTIOfficial title:
Influence of Implant Component Materials on Peri-implant Soft Tissue Host-response: A Randomized Clinical Trial.
Verified date | April 2023 |
Source | University of Liege |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | October 1, 2022 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Hospital University of Liège (CHU-Ulg) | Liège |
Lead Sponsor | Collaborator |
---|---|
University of Liege | ITI International Team for Implantology, Switzerland |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | dental plaque accumulation | To assess the amount of plaque present on the abutments with SEM analysis. semi quantitative analyses are performed on the abutment. | 8 weeks | |
Secondary | 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. | 8 weeks | |
Secondary | Soft tissue health changes assessed by Plaque Index | Assessment of plaque percentage | 8 weeks | |
Secondary | Soft tissue health changes assessed by Keratinized gingiva measure | Assessment of height of keratinized mucosa by probing in mm. | 8 weeks | |
Secondary | Soft tissue health changes assessed by soft tissues height | Assessment of height of soft tissue by probing in mm. | 8 weeks |
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