3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Liquid S-Platelet Rich Fibrin as a Potential Adjunct in Conservative Closed Periodontal Debridement for Periodontitis Stages II-IV: A Randomized, Split-mouth, 3-month Clinical Trial
Mahsa University
14 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria13
- 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
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Interventions
Full mouth scaling or professional mechanical plaque removal, air polishing, and root debridement wherever deep pockets are indicated, then normal saline irrigation after root debridement
Full mouth scaling or professional mechanical plaque removal, air polishing, and root debridement wherever deep pockets are indicated, then liquid S-PRF irrigation after root debridement
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07293962