Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry

Overview

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.

Detailed description

The study will involve a total of 40 edentulous patients, each missing four teeth in the posterior region of the mandible or maxillae. Each patient will receive four dental implants and single crowns made from different materials. The primary objectives are to evaluate biomarkers in peri-implant crevicular fluid and to assess the changes in these biomarkers after three and six months of loading. This research will help determine the biocompatibility of the materials and their potential to cause peri-implantitis.

Interventions

• Device Dental Crown with Titanium-Abutment
  Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such a
• Device Dental Crown with PEEK (Polyetheretherketone)-Abutment
  Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such a
• Device Dental Crown with Zirconia-Abutment
  Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such a
• Device Dental Crown with Lithium-Disilicate-Abutment (e.max)
  Participants in this clinical trial will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK (Polyetheretherketone), zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae. The study will evaluate the impact of these materials on peri-implant soft tissue health by measuring inflammatory markers in the peri-implant crevicular fluid and assessing clinical outcomes such a

Primary outcome measures

• Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid [Time frame: 3 and 6 months post-implantation]

Secondary outcome measures (2)

• Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth [Time frame: 3 and 6 months post-implantation]
• Clinical Measurements of Pocket Depth [Time frame: 3 and 6 months post-implantation]

Eligibility criteria

Inclusion criteria

• Participants must be 18 years or older.
• Participants must be edentulous with at least four missing teeth in the posterior region of the mandible or maxillae.
• Participants must have appropriate oral hygiene and periodontal status of natural teeth, with a pocket depth of 4mm or less and no bleeding.
• Dental implants must be fully integrated with no bone resorption or inflammation after three months of implant placement, confirmed by X-ray and clinical examination.
• Implant placement must be into natural bone without additional procedures such as sinus lift or bone augmentation.
• The procedure must be a standard implantation with no immediate implant placement.
• The height of the gingiva must be at least 3mm or more.

Exclusion criteria

• Patients with systemic diseases such as malignancy, diabetes, osteoporosis, or rheumatoid arthritis.
• Patients with a history of periodontal treatment.
• Patients who smoke or use tobacco.
• Patients who have received antibiotic treatment within three months prior to implantation.
• Pregnant individuals.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Lithuania · 1 center

• VIC Clinic — Vilnius

Identifiers

NCT: NCT06554041 · BE-2-106

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗