Evaluation of Sinus Augmentation Bone Healing Using Autograft and Xenograft Compared to Xenograft… (NCT06247098) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Sinus Augmentation Bone Healing Using Autograft and Xenograft Compared to Xenograft Alone
United States10 participantsStarted 2024-09-01
Plain-language summary
To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.
Who can participate
Age range
18 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:
* Patients of Tufts School of Dental Medicine (TUSDM)
* Two stage sinus augmentations with \<5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement
* Full maxillary edentulism or Kennedy class I or III
* 18 to 100 year old
Exclusion Criteria:
* Adults unable to consent (cognitively impaired adults)
* Those who self-report as pregnant or breastfeeding
* Wards of the state
* Non-Viable neonates
* Neonates of uncertain viability
* \< 18 years of age
* Refusal to participate
* Prior medical condition causing complications in bone metabolism
* Osteoporosis
* History of/or current chemotherapy
* History of/or current head and neck radiation
* Current heavy smoking \> 10 cigarettes/day
* Self-reported pregnancy or lactation
* Previous history of sinus elevation procedure
* Existing sinus pathology or pathology discovered at time of sinus augmentation or implant placement
* Absence of autogenous donor site
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.