Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarvard Medical School (HMS and HSDM)

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dental Crown with Titanium-Abutment
  • Dental Crown with PEEK (Polyetheretherketone)-Abutment
  • Dental Crown with Zirconia-Abutment
  • Dental Crown with Lithium-Disilicate-Abutment (e.max)

Treatment groups

40 Participants
are divided into 4 treatment groups