Effects of different materials on gum tissue around dental implants
Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
This study tests how different materials used in dental implants affect the gum health of patients without teeth over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Harvard Medical School (HMS and HSDM) Academic / other |
| Locations | 1 site (Vilnius) |
| Trial ID | NCT06554041 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate how various restorative materials used in dental implants, including titanium, PEEK, zirconia, and lithium disilicate, influence the surrounding gum tissue in edentulous patients. A total of 40 participants will receive four dental implants made from these materials, and their peri-implant crevicular fluid will be analyzed for inflammation markers at 3 and 6 months post-implantation. Regular dental check-ups will assess gum health, focusing on bleeding and pocket depth around the implants. The study seeks to determine the biocompatibility of these materials and their potential to cause peri-implantitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are edentulous with at least four missing teeth in the posterior region of the mandible or maxillae.
Not a fit: Patients with systemic diseases, a history of periodontal treatment, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental implant materials that minimize inflammation and enhance oral health.
How similar studies have performed: Previous studies have shown varying degrees of success with different implant materials, but this specific comparison of these four materials is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vilnius
- VIC Clinic — Vilnius, Lithuania (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.