Evaluating a new dental implant system for immediate tooth restoration

Clinical and Radiographic Evaluations of Hiossen EK III NH Dental Implants

This study is testing a new dental implant system to see if it can help people with missing teeth get immediate replacements that work well over time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Harvard Medical School (HMS and HSDM) (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06651502 on ClinicalTrials.gov

What this trial studies

This study aims to assess the performance of a new dental implant system (EK III NH) designed for immediate restoration in patients with missing teeth. Over a two-year period, the implants will be placed in the upper and lower jaws, and patients will receive temporary restorations immediately after placement. The study will monitor the implants' performance through regular dental check-ups and X-rays, focusing on factors such as primary and secondary stability influenced by implant design and surface treatments. The goal is to improve the predictability and success of dental implants in clinical practice.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 20-80 seeking dental implants to replace missing teeth without significant medical complications.

Not a fit: Patients with a history of failed dental implants, those requiring grafting procedures, or individuals with untreated oral infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the reliability and effectiveness of immediate dental implants for patients with missing teeth.

How similar studies have performed: Previous studies have shown promising results with similar approaches in dental implant technology, indicating potential for success.

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.

Where this trial is running

Boston, Massachusetts

• Harvard Dental Center — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: David Kim, DDS, DMSc — Harvard School of Dental Medicine
• Study coordinator: David Minjoon Kim, DDS, DMSc

Conditions: Missing Teeth, dental implant, immediate provisionalization