Efficacy of a Dental Implant System for Immediate Restoration

Launched by HARVARD MEDICAL SCHOOL (HMS AND HSDM) · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of dental implant system designed to help people who are missing teeth. The goal is to see how well these implants, called EK III NH dental implants, perform over two years. When patients receive these implants, they will also get a temporary tooth right away. Throughout the study, dental professionals will keep track of how the implants are doing through regular check-ups and X-rays.

To participate in this trial, you should be between 20 and 80 years old and need dental implants to replace missing teeth. You’ll need to be in good health and not taking any medications that could affect the study results. If you decide to join, you can expect to attend follow-up visits to monitor your progress. It's important to know that some people won't be able to participate, like those with certain dental issues or health conditions. If you have any questions or think you might qualify, don't hesitate to reach out for more information!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, between 20-80 years of age, who request dental implant treatment options to replace missing teeth as part of comprehensive dental care
• • Subjects are willing to sign an informed consent, participate, and return for follow-up visits.
• • Subjects without significant medical history and currently not on medications that might complicate the results
• Exclusion Criteria:
• • Subjects who do not meet all the inclusion criteria or will not cooperate with the protocol schedule.
• • Subjects who received and failed a previously placed dental implant.
• • Subjects who require a bone and soft tissue grafting procedure prior to or at the time of the implant placement.
• • Subjects with significant untreated periodontal disease, caries, infection, or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
• • Subjects who have used nicotine-containing products within three weeks prior to surgery.
• • Subjects who are insulin-dependent diabetic or if their Hgb1c levels \> 6.5%.
• • Subjects with a history of malignancy within the past five years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
• • Subjects who are nursing or pregnant.
• • Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that is known to affect bone turnover.
• • Subjects with diseases affecting bone metabolism (excluding idiopathic osteoporosis).
• • Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
• • Acutely infected defect site.