Actively Recruiting
Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
Led by Harvard Medical School (HMS and HSDM) · Updated on 2024-08-14
40
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how different materials used in dental implants affect the surrounding gum tissue in adults who need implants. This study focuses on understanding inflammation around dental implants made from titanium, PEEK, zirconia, and lithium disilicate. The goal is to compare these materials to determine which causes the least inflammation by measuring changes in inflammatory markers after 3 and 6 months. The study involves 40 patients missing at least four teeth in the back of the lower or upper jaw. Each patient will receive four dental implants and crowns made from each of the four materials. Researchers will evaluate the effects of each material on gum tissue by measuring markers of inflammation and clinical signs like bleeding and pocket depth around the implants at 3 and 6 months after placement. Participants will have fluid samples taken from around their implants at 3 and 6 months to analyze inflammation markers. Regular dental check-ups will measure gum health, including bleeding on probing and pocket depth. The study will monitor these outcomes to assess biocompatibility and potential risks of peri-implantitis. The total participation period includes these follow-up assessments after implant placement.
CONDITIONS
Brief Title
Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Participants must be missing at least four teeth in the back of the upper or lower jaw.
- Participants must have good oral hygiene and healthy gums with pocket depth of 4mm or less and no bleeding.
- Dental implants must be fully integrated with no bone loss or inflammation after 3 months, confirmed by X-ray and examination.
- Implants must be placed into natural bone without additional procedures like sinus lift or bone graft.
- Implantation must be standard with no immediate placement.
- Gingiva height must be at least 3mm or more.
You will not qualify if you...
- Patients with systemic diseases like cancer, diabetes, osteoporosis, or rheumatoid arthritis.
- Patients with a history of periodontal treatment.
- Patients who smoke or use tobacco.
- Patients who have taken antibiotics within 3 months before implantation.
- Pregnant individuals.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Standard implantation procedure without immediate placement
Participants will receive dental implants and single screw-retained crowns made from one of four different materials: titanium, PEEK, zirconia, or lithium disilicate (e.max). The implants will be placed in the posterior region of the mandible or maxillae.
1 visit (in-person)
Duration - 6 months post-implantation
Participants are monitored to assess soft tissue response and biocompatibility of the implant materials by measuring inflammatory biomarkers and clinical outcomes such as bleeding on probing and pocket depth.
Visits at 3 and 6 months post-implantation
Trial Site Locations
Total: 1 location
1
VIC Clinic
Vilnius, Lithuania, 01362
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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