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Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry

Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry

Recruiting
18 years and older
All
Phase N/A

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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.

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.

Eligibility

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.

Study details
    Edentulous Alveolar Ridge
    Peri-Implantitis
    Peri-implant Mucositis
    Prosthetic Infection
    Prosthetic Complication

NCT06554041

Harvard Medical School (HMS and HSDM)

23 August 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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