About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Normal saline irrigation
Procedure/SurgeryFull mouth scaling or professional mechanical plaque removal, air polishing, and root debridement wherever deep pockets are indicated, then normal saline irrigation after root debridement
Platelet rich fibrin
DrugFull 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
Treatment groups
Trial outcomes
Primary outcomes
Periodontal probing depth
Measurement of periodontal pocket depth from gingival margin to base of pocket using UNC-15 probe with and without research stent
Clinical attachment level
Sum of measurement of periodontal pocket depth from gingival margin to base of pocket and marginal gingiva level from cementoenamel junction to gingival margin using UNC-15 probe with and without research stent
Number of bleeding sites
Record of scored, assessed bleeding after periodontal probing
Secondary outcomes
Full mouth plaque score
Record of assessed plaque presence in percentage of all sites and total score using Plaque Index System
Full mouth bleeding score
Record of assessed bleeding on probing in percentage of all sites and total score using modified Sulcular Bleeding Index
Gingival margin level & relative clinical attachment level
Measurement of marginal gingiva level from cementoenamel junction to gingival margin using UNC-15 probe with and without research stent
Sponsors and contacts
Click on the lead sponsor to view all of their trials.