Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2023
CompletedFirst Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedAugust 14, 2024
August 1, 2024
1.9 years
August 5, 2024
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth
3 and 6 months post-implantation
Clinical Measurements of Pocket Depth
3 and 6 months post-implantation
Study Arms (4)
Dental Crown with Titanium-Abutment
EXPERIMENTALParticipants in this arm will receive dental implants and single crowns made from titanium. The impact of titanium on peri-implant soft tissue health will be evaluated by measuring inflammatory markers and clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with PEEK (Polyetheretherketone)-Abutment
EXPERIMENTALParticipants in this arm will receive dental implants and single crowns made from PEEK. The study will assess the biocompatibility of PEEK by examining inflammatory responses and clinical outcomes, including bleeding on probing and pocket depth, at 3 and 6 months post-implantation.
Dental Crown with Zirconia-Abutment
EXPERIMENTALParticipants in this arm will receive dental implants and single crowns made from zirconia. The effects of zirconia on peri-implant soft tissue will be analyzed by measuring the levels of inflammatory markers and observing clinical outcomes such as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with Lithium-Disilicate-Abutment (e.max)
EXPERIMENTALParticipants in this arm will receive dental implants and single crowns made from lithium disilicate (e.max). The study will evaluate the biocompatibility of e.max by measuring inflammatory markers and clinical outcomes, including bleeding on probing and pocket depth, at 3 and 6 months post-implantation.
Interventions
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VIC Clinic
Vilnius, 01362, Lithuania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 14, 2024
Study Start
August 23, 2023
Primary Completion
July 1, 2025
Study Completion
January 1, 2026
Last Updated
August 14, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available after the primary and secondary outcomes have been published, and will remain accessible for five years following the end of the study.
- Access Criteria
- Researchers can request access to the IPD by contacting the principal investigator. Requests should include a research proposal and a data use agreement.
Individual participant data (IPD) will be made available to other researchers upon reasonable request. The data will include de-identified participant data, relevant clinical and biochemical measurements, and any other pertinent data collected during the study.