NCT06554041 Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
| NCT ID | NCT06554041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Harvard Medical School (HMS and HSDM) |
| Condition | Edentulous Alveolar Ridge |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-08-23 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT06554041 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Edentulous Alveolar Ridge. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06554041 currently recruiting?
Yes, NCT06554041 is actively recruiting participants. Visit ClinicalTrials.gov or contact Harvard Medical School (HMS and HSDM) to inquire about joining.
Where is the NCT06554041 trial being conducted?
This trial is being conducted at Vilnius, Lithuania.
Who is sponsoring the NCT06554041 clinical trial?
NCT06554041 is sponsored by Harvard Medical School (HMS and HSDM). The trial plans to enroll 40 participants.