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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00163605
Eligibility Criteria:
Inclusion criteria:
* Written informed consent obtained from the subject prior to participation in the study
* At least 18 years of age
* Partially or totally edentulous with an atrophic posterior maxilla requiring unilateral or bilateral sinus lift before dental implant placement
* In case of bilateral sinus lifts, both sides are operated on the same day.
* Subjects with remaining minimal maxillary bone height between 2 mm and 5 mm at the site with minimal height in the area where implants are planned, and a remaining maxillary bone thickness \>= 5 mm in the area where implants are planned
Exclusion Criteria:
* Previous or coeval major surgical intervention in the targeted area, or major surgical intervention in the targeted area planned within the next 18 months (like Caldwell Luc) (minor interventions like surgical tooth extraction or root tip resections are allowed)
* Surgical tooth extraction in the targeted area less than three months before the SLP
* Maxillary and sinus disorders including: acute sinusitis, chronic sinus pathology, retained root tips, polyps, tumors, and cysts in antral cavity or odontogenic cysts, alveolar scar ablation
* Major occlusal disturbance, like severe bruxism
* Uncontrolled\* periodontal disease
* An inadequate interarch distance requiring an oppositional graft
* Immune system disorders, immunodeficiency or immunosuppression
* Known coagulation disorder
* Uncontrolled\* diabetes mellitus
* Severe hyperparathyroidism
* Receiving long-term anti-inflammatory treatment with NSAIDs or corticosteroids
* Chemotherapy current or in the last three months
* Having undergone maxillary radiation therapy
* Known hypersensitivity to aprotinin or to other components of the investigational product
* Abuse of alcohol or drugs or tobacco consumption of more than 5 cigarettes per day at study start
* Non-compliant for future dental hygiene
* Severely compromised physical and psychological health, that in the investigators opinion will affect patient compliance
* Any contra-indications to the use of MBCP, which are defined as osteomyelitis, degenerative bone disease or necrosis of the recipient site
* Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
* Pregnant or lactating, or intending to become pregnant during the study period
* Uncontrolled = not treated or not stabilized after treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00163605
Study Brief:
Protocol Section:
NCT00163605