NCT07293962 3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
| NCT ID | NCT07293962 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mahsa University |
| Condition | Periodontitis Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 14 participants in total. It began in 2024-04-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
What is the purpose of this study? This study is to investigate the effect of a processed blood product in healing after treatment for gum disease. In addition to scaling \& root debridement (deep cleaning) that is the standard treatment for periodontitis, this study will test the effectiveness of patient's processed blood in improving healing of diseased gums. What are the procedures to be followed? First, all patients will undergo dental check-up and X-ray imaging for suitability as a participant for the project. For participants who are eligible and included into study, upper \& lower jaws models will be made, and each will be given oral care kit \& instructions. The next appointment will be given for scaling \& root debridement with local numbing agent in one day. Towards the end of the treatment, a small amount (20 mℓ) of blood will be collected and spun to produce liquid platelet-rich fibrin that is then used to flush the treated gum pockets in half of the mouth. For the treated gum pockets in the opposite half of the mouth, sterile salt water (saline) will be used instead for comparison. Then, follow-up appointments are at monthly intervals until 3 months. Who should enter the study? Symptoms of gum disease include bleeding and/or receding gums, tooth/teeth appearing longer or feeling shaky/loose/weak, formation of large amount of calculus and/or black/empty space between teeth, frequent/recurrent gum swelling/pus, and/or bad breath.
Eligibility Criteria
Inclusion Criteria: * Have at least 20 teeth, * American Society of Anesthesiology class I or II * Periodontitis stages II-IV * Bilateral sites of deep periodontal pockets ≥5 mm Exclusion Criteria: * Limited mouth opening or symptomatic temporomandibular joint disorder * Inability to tolerate extended long periodontal treatment and/or hyperactive gag reflex * Current or former smoker or vape user * Pregnant and/or breastfeeding * Having diabetes mellitus type I or II * Having bleeding disorder or is on anticoagulants * Underwent periodontal treatment and/or surgery in past 6 months prior * Undergoing orthodontic therapy, or completed in past 3 months prior * On or had anti-inflammatory drug(s) in past 3 months prior * On or had antibiotic(s) in past 3 months prior * Having autoimmune disorder * On or had immunosuppressant drug(s) in past 3 months prior * Undergoing or underwent radio- and/or chemo-therapy
Frequently Asked Questions
Who can join the NCT07293962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Periodontitis Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07293962 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07293962 currently recruiting?
Yes, NCT07293962 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mahsa University to inquire about joining.
Where is the NCT07293962 trial being conducted?
This trial is being conducted at Jenjarum, Malaysia.
Who is sponsoring the NCT07293962 clinical trial?
NCT07293962 is sponsored by Mahsa University. The trial plans to enroll 14 participants.