Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
Launched by HARVARD MEDICAL SCHOOL (HMS AND HSDM) · Aug 12, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how different materials used in dental implants can affect the surrounding gum tissue in adults who need dental implants. The researchers want to find out how materials like titanium, PEEK, zirconia, and lithium disilicate impact inflammation in the gums around the implants. They will collect fluid samples from around the implants at 3 and 6 months after placement and check the health of the gums through regular dental visits to see which material leads to the least inflammation.
To participate, you need to be at least 18 years old and have missing teeth in the back of your jaw. It's important that you have good oral hygiene and healthy gums, with no bleeding or deep pockets around your natural teeth. The study is looking for individuals without certain health conditions, such as diabetes or cancer, and those who do not smoke or have recently taken antibiotics. Participants will receive dental implants made from different materials and will be monitored regularly to ensure their gum health is tracked over time.
Gender
ALL
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.
About Harvard Medical School (Hms And Hsdm)
Harvard Medical School (HMS) and Harvard School of Dental Medicine (HSDM) are prestigious institutions renowned for their commitment to advancing medical and dental research, education, and patient care. As clinical trial sponsors, HMS and HSDM leverage their robust academic resources, cutting-edge laboratories, and a collaborative network of healthcare professionals to conduct innovative research that addresses critical health challenges. With a focus on translating scientific discoveries into clinical applications, these institutions foster an environment that promotes ethical research practices and prioritizes participant safety, ensuring that their clinical trials contribute significantly to the field of medicine and the well-being of communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vilnius, , Lithuania
Patients applied
GM
SS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported