Efficacy of a Dental Implant System for Immediate Restoration

Running, not enrolling · Not applicable

Conditions studied: Missing Teeth

In brief

The primary objective of this study is to observe the performance of an implant system with a new surface (EK III NH dental implants) over a period of two years. The implants will be placed in the upper and lower jaws of patients with missing teeth and immediately given a temporary restoration. The investigators will document the performance of the implants through regular dental check-ups and X-rays.

Key facts

Study ID

NCT06651502

Run by

Harvard Medical School (HMS and HSDM)

People needed

30

Starts

2025-01-01

Expected to finish

2026-12-31

Last updated by the study team

2026-02-25

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Harvard Dental Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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