Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
NCT Number: NCT06554041
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Edentulous Alveolar Ridge|Peri-Implantitis|Peri-implant Mucositis|Prosthetic Infection|Prosthetic Complication
Interventions: DEVICE: Dental Crown with Titanium-Abutment|DEVICE: Dental Crown with PEEK (Polyetheretherketone)-Abutment|DEVICE: Dental Crown with Zirconia-Abutment|DEVICE: Dental Crown with Lithium-Disilicate-Abutment (e.max)
Sponsor: Harvard Medical School (HMS and HSDM)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2023-08-23
Completion Date: 2026-01-01
Locations: VIC Clinic, Vilnius, 01362, Lithuania

Summary:
The goal of this clinical trial is to learn how different materials used in dental implants affect the surrounding gum tissue in adults who need dental implants. The main questions it aims to answer are:

How do different materials (titanium, PEEK, zirconia, and lithium disilicate) affect inflammation around dental implants? What changes occur in inflammation markers in the gum tissue after 3 and 6 months? Researchers will compare the different materials to see which one causes the least amount of inflammation.

Participants will:

Receive dental implants made from different materials. Have samples of fluid from around their implants collected for analysis at 3 and 6 months.

Undergo regular dental check-ups to measure gum health, such as bleeding and pocket depth around the implants.

Primary Outcome Measures: Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid, The primary outcome measure will evaluate the concentration of inflammatory biomarkers in the peri-implant crevicular fluid, including IL-6, IL-8, IL-10, IL-17, TNF-alpha, IL-12, IL-1-beta, and IL-4. These biomarkers all have the same unit and will be measured to assess the inflammatory response of peri-implant soft tissue to different prosthetic materials (titanium, PEEK, zirconia, and lithium disilicate). The goal is to determine which material induces the least amount of inflammation, indicating better biocompatibility and a lower risk of peri-implantitis., 3 and 6 months post-implantation
Secondary Outcome Measures: Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth, The secondary outcome measure will assess the clinical health of the peri-implant tissue by measuring bleeding on probing (BOP) around the dental implants. These clinical parameters will provide additional insights into the soft tissue response to the different prosthetic materials used in the implants (titanium, PEEK, zirconia, and lithium disilicate). Improved clinical outcomes, such as reduced bleeding and shallower pocket depths, will indicate better biocompatibility and integration of the implant materials., 3 and 6 months post-implantation|Clinical Measurements of Pocket Depth, The secondary outcome measure will assess the clinical health of the peri-implant tissue by measuring pocket depth around the dental implants. These clinical parameter will provide additional insights into the soft tissue response to the different prosthetic materials used in the implants (titanium, PEEK, zirconia, and lithium disilicate). Improved clinical outcomes, such as reduced bleeding and shallower pocket depths, will indicate better biocompatibility and integration of the implant materials., 3 and 6 months post-implantation