Histologic and Histomorphometric Evaluation of Lateral Maxillary Sinus Augmentation With or Witho… (NCT07348198) | Clinical Trial Compass
CompletedNot Applicable
Histologic and Histomorphometric Evaluation of Lateral Maxillary Sinus Augmentation With or Without Platelet-Rich Fibrin
Turkey (Türkiye)21 participantsStarted 2025-04-07
Plain-language summary
This study evaluates bone healing after lateral maxillary sinus lift surgery performed prior to dental implant placement. This surgical procedure is commonly used when there is insufficient bone height in the upper jaw to support dental implants.
Patients who required sinus lift surgery on both sides of the upper jaw were included in the study. In each patient, one side was treated with a demineralized freeze-dried bone allograft (DFDBA) alone, while the opposite side received the same bone graft combined with platelet-rich fibrin (PRF). PRF is a blood-derived material prepared from the patient's own blood and is thought to support tissue healing. The treatment side receiving PRF was determined randomly.
Six months after the sinus lift surgery, dental implants were placed. At that time, small bone samples were collected from the grafted areas. These samples were examined under a microscope to assess new bone formation and the amount of remaining graft material.
The purpose of this study was to determine whether adding PRF to DFDBA improves bone regeneration compared with DFDBA alone during lateral maxillary sinus augmentation.v
Who can participate
Age range
18 Years – 70 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 aged 18 to 70 years.
* Patients requiring bilateral lateral maxillary sinus augmentation for dental implant placement.
* Adequate residual alveolar bone height allowing for lateral sinus floor elevation.
* Good general health (ASA I or II).
* Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
* Presence of systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis).
* History of head and neck radiotherapy.
* Use of medications known to affect bone healing (e.g., bisphosphonates, corticosteroids).
* Active sinus pathology or chronic sinusitis.
* Heavy smoking (\>10 cigarettes per day).
* Pregnancy or lactation.
* Poor oral hygiene or untreated periodontal disease.
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 New Bone Formation (%)
Timeframe: 6 months after lateral maxillary sinus augmentation