Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT06651502
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT06651502
Study Brief:
Protocol Section:
NCT06651502