Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
NCT ID: NCT06554041
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-08-23
2026-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
The study is open-label, meaning that both the researchers and the participants will know which material is being used for each patient. This design is intended to evaluate the impact of these different materials on the health of the peri-implant soft tissue by measuring inflammatory markers and clinical outcomes such as bleeding on probing and pocket depth over a six-month period.
DIAGNOSTIC
NONE
Study Groups
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Dental Crown with Titanium-Abutment
Participants 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 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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with PEEK (Polyetheretherketone)-Abutment
Participants 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 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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with Zirconia-Abutment
Participants 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 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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Dental Crown with Lithium-Disilicate-Abutment (e.max)
Participants 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.
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Interventions
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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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
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 as bleeding on probing and pocket depth at 3 and 6 months post-implantation.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
Responsible Party
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Samuel Akhondi
Research Associate
Locations
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VIC Clinic
Vilnius, , Lithuania
Countries
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Facility Contacts
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Other Identifiers
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BE-2-106
Identifier Type: -
Identifier Source: org_study_id
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