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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07419269
Eligibility Criteria:
INCLUSION CRITERIA
* 1-4 missing teeth that need to be replaced with dental implants
* Bone ridge width insufficient for dental implant placement; \<5 mm of width as measured in a cone beam computed tomography at the ideal prosthetic position
* Medically healthy with no known allergies to antibiotics
* Non-smoker or light smoker (\< 10) or previous smoker who had quit for 5 years or more
* Periodontal health, as confirmed by clinical examination (Full mouth bleeding score and full mouth plaque score \< 25%) and at least one neighboring natural tooth to the defect site(s)
* Age of 18 or above
EXCLUSION CRITERIA
* All contraindications against implant treatment or augmentative procedures (e.g., advanced systemic diseases, corticosteroid medication, immunodeficiency, pregnancy, intention to become pregnant, breastfeeding, lack of safe contraception)
* Treatments or diseases that may have an effect on bone turnover or the bone itself or non-mineralized tissue metabolism (e.g., bisphosphonates or local radiotherapy, skeletal immaturity)
* Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone diseases
* Any active malignancy or patient undergoing treatment for a malignancy Study protocol: IndiALLO Version 4/19.03.2025 Page 9 von 32
* Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product
* Persistent compartment syndrome or neurovascular residua of compartment syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07419269
Study Brief:
Protocol Section:
NCT07419269