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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT05602493
Eligibility Criteria:
Inclusion Criteria:
* Provide signed and dated informed consent form.
* Overall, healthy patients that qualify for oral surgery (ASA I and II).
* Male and female patients 18-90 (inclusive) years of age.
* Requiring extraction of 1 tooth (maxillary or mandibular).
* Stable post-extraction socket walls with at least 4 walls.
* Adequate oral hygiene: plaque index \< 25% before the surgery.
* Non-smoker or smoker of \<10 cigarettes per day.
* Able to follow the instructions and able to meet the follow-ups.
* Healthy or controlled periodontal disease.
Exclusion Criteria:
* Patients who do not agree with informed consent.
* Male and female patients are not 18-90 (inclusive) years of age. Patients taking medication that can interfere with the treatment such as Calcium Carbonate or Vitamin D.
* Untreated periodontal disease.
* Presence of dehiscence and/or fenestration at buccal plate of the extraction tooth/teeth.
* Patient who will need guided bone regeneration (GBR) or Block Regeneration after the extraction.
* History of head and/or neck radiation.
* History of chemotherapy in the five years prior of the surgery.
* Non controlled Diabetes.
* Chronic corticoids medication that may influence healing and/or osseointegration.
* Smoker of \>10 cigars per day.
* Pregnant woman
* Alcohol or drugs.
* Patient going under bisphosphonates treatment or taking Denosumab (Prolia®).
* Patient with diagnosed osteoporosis, hypocalcemia, hypersensibility to alendronic acid or any of the excipients of Soludronate®.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05602493
Study Brief:
Protocol Section:
NCT05602493