PRF vs. Graftless Sinus Lift With Implant Placement (NCT07090694) | Clinical Trial Compass
By InvitationPhase 1
PRF vs. Graftless Sinus Lift With Implant Placement
Saudi Arabia8 participantsStarted 2025-02-01
Plain-language summary
The goal of this clinical trial is to evaluate the effectiveness of sinus floor elevation using platelet-rich fibrin (PRF) compared to a graftless approach in adult patients with atrophic posterior maxilla (residual bone height 5-7 mm) requiring dental implant rehabilitation. The main questions it aims to answer are:
Does PRF enhance bone height gain more effectively than graftless sinus elevation? Does PRF improve implant stability and reduce marginal bone loss compared to the graftless approach? Researchers will compare the outcomes of PRF-grafted implants versus non-grafted implants to see if PRF improves radiographic and clinical results in single-stage implant placement.
Participants will:
Undergo internal sinus lift via crestal drilling approach
Be randomly assigned to one of two groups:
Group I: sinus lift without graft material Group II: sinus lift with PRF as the sole grafting material Receive simultaneous dental implant placement during the sinus lift Be monitored through clinical exams and radiographic imaging over 6 months postoperatively
Who can participate
Age range
25 Years – 65 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 25 to 65 years
* Patients with one or more missing posterior maxillary teeth
* Residual alveolar bone height between 5 mm and 7 mm, confirmed by CBCT
* Good oral hygiene and motivation for implant therapy
* Adequate inter-arch space for prosthetic rehabilitation
* Absence of maxillary sinus pathology on radiographic assessment
* Patients willing to undergo single-stage implant placement with sinus lift
* Signed informed consent
Exclusion Criteria:
* Systemic diseases or medical conditions affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis, immunocompromised status)
* History of radiation therapy in the head and neck region
* Use of medications influencing bone turnover (e.g., bisphosphonates, corticosteroids)
* Active periodontal disease or poor oral hygiene
* Smoking or tobacco use
* Parafunctional habits such as bruxism or clenching
* Pregnancy or breastfeeding
* Known bleeding disorders or abnormal coagulation profiles
* Presence of maxillary sinus infection or pathology
* Inability to attend follow-up visits or comply with study protocol
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.