Clinical trial NCT06554041: Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
Official title: Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge
Peri-Implantitis
Peri-implant Mucositis
Prosthetic Infection
Prosthetic Complication
Keywords: Dental Implants
Peri-Implant Soft Tissue
Prosthetic Materials
Inflammation Markers
Oral Health
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical trial employs an interventional study model with a parallel assignment. A total of 40 edentulous patients, will be randomized into four groups.

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.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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 criteria: 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.

Primary outcomes:
measure: Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid
timeFrame: 3 and 6 months post-implantation
Secondary outcomes:
measure: Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth
timeFrame: 3 and 6 months post-implantation
measure: Clinical Measurements of Pocket Depth
timeFrame: 3 and 6 months post-implantation
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: VIC Clinic
Study officials:
References: