Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry

Harvard Medical School (HMS and HSDM)

Status: Enrolling

Conditions: Edentulous Alveolar Ridge; Prosthetic Infection; Peri-implant Mucositis; Prosthetic Complication; Peri-Implantitis

Treatments: Device: Dental Crown with Lithium-Disilicate-Abutment (e.max); Device: Dental Crown with Titanium-Abutment; Device: Dental Crown with PEEK (Polyetheretherketone)-Abutment; Device: Dental Crown with Zirconia-Abutment

Study type: Interventional

Funder types: Other

Identifiers

NCT06554041

BE-2-106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 4 patient groups

Dental Crown with Titanium-Abutment

Experimental group

Description:

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.

Treatment:

Device: Dental Crown with Titanium-Abutment

Dental Crown with PEEK (Polyetheretherketone)-Abutment

Experimental group

Description:

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.

Treatment:

Device: Dental Crown with PEEK (Polyetheretherketone)-Abutment

Dental Crown with Zirconia-Abutment

Experimental group

Description:

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.

Treatment:

Device: Dental Crown with Zirconia-Abutment

Dental Crown with Lithium-Disilicate-Abutment (e.max)

Experimental group

Description:

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.

Treatment:

Device: Dental Crown with Lithium-Disilicate-Abutment (e.max)