The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Proce… (NCT00868777) | Clinical Trial Compass
CompletedPhase 4
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
United States25 participantsStarted 2008-01
Plain-language summary
The hypothesis of this study is that there is a significant difference in bone maturation after sinus grafting determined by the distance from the buccal to the palatal wall of this cavity.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults patients (Older than 18 years), up to 85 years-old.
* Physical status according to the American Society of Anesthesiologists (ASA) I or II
* Patient in need of a sinus grafting using the lateral approach to allow the proper placement of dental implants. The remaining bone height must be 3 mm or less.
* No uncontrolled systemic disease or condition known to alter bone metabolism
* Adequate oral hygiene (O'Leary plaque score ≤20%)
Exclusion Criteria:
* Long term (\>2 weeks) use of antibiotics in the past 3 months
* Patients smoking more than half-pack a day
* Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, etc…)
* Pregnant or attempting to get pregnant
* Patients that don't meet the indications for sinus grafting (Existing sinus conditions, sepsis, history of cancer and/or radiation to the oral cavity, use of biphosphonates, pregnancy), or have postoperative complications related to those conditions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Histomorphometric proportion of vital bone
Timeframe: Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement