The Present Study Was Performed to Evaluate the Efficacy of Lyophilized-PRF in Treatment of Perio… (NCT06625528) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
The Present Study Was Performed to Evaluate the Efficacy of Lyophilized-PRF in Treatment of Periodontal Intra-bony Defects
Egypt36 participantsStarted 2023-11-19
Plain-language summary
The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through:
1. Primary outcomes:
* The clinical parameters including: Probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain.
* The radiographic parameters including: Marginal bone level (MBL), bone-defect fill.
2. Secondary outcome: The level of BMP-2 in Gingival crevicular fluid (GCF).
Who can participate
Age range
20 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:
* All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
* 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability.
* All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings
Exclusion Criteria:
* Any patients with any systemic condition that contraindicate any surgical intervention.
* Pregnant or lactating females, smokers, or alcoholic patients.
* Patients with intra-bony defects received drugs that affect bone turnover such as (chemotherapy and radiotherapy).
* History of periodontal therapy and antibiotic administration in the last 6 months.
* Patients taking any medicine which may affect the function of platelet (i.e., aspirin) in the previous 3 months.
* Miller grade II or greater mobility, furcation involvement as well as one-wall defects and interdental craters.
* Patients with unacceptable oral hygiene after the re-evaluation of phase I therapy.
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
radiographic parameters
Timeframe: baseline, 3, 6, and 9 months after treatment
2
clinical parameters
Timeframe: baseline, 3, 6, and 9 months after treatment.