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NCT Number: NCT06554041

Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry

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.

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Key information

Conditions

Edentulous Alveolar Ridge Mouth Diseases Peri-Implantitis Peri-implant Mucositis Periodontal Diseases Prosthetic Complication Prosthetic Infection Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental Crown with Titanium-Abutment

Device

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

Device

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

Device

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)

Device

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.

Primary outcomes

  1. Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid

    Time frame: 3 and 6 months post-implantation

    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.

Secondary outcomes

  1. Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth

    Time frame: 3 and 6 months post-implantation

    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.

  2. Clinical Measurements of Pocket Depth

    Time frame: 3 and 6 months post-implantation

    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.

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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