3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMahsa University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Normal saline irrigation

    Procedure/Surgery

    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

  • Platelet rich fibrin

    Drug

    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

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Control half of mouthPlacebo comparator 1 intervention
Group B: Experimental half of mouthExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Periodontal probing depth

Measurement of periodontal pocket depth from gingival margin to base of pocket using UNC-15 probe with and without research stent

Time frame
Baseline immediately before treatment and 3-months post-operative
2

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

Time frame
Baseline immediately before treatment and 3-months post-operative
3

Number of bleeding sites

Record of scored, assessed bleeding after periodontal probing

Time frame
Baseline immediately before treatment and 3-months post-operative

Secondary outcomes

1

Full mouth plaque score

Record of assessed plaque presence in percentage of all sites and total score using Plaque Index System

Time frame
Baseline immediately before treatment and monthly up to 3-months post-operative
2

Full mouth bleeding score

Record of assessed bleeding on probing in percentage of all sites and total score using modified Sulcular Bleeding Index

Time frame
Baseline immediately before treatment and monthly up to 3-months post-operative
3

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

Time frame
Baseline immediately before treatment and 3-months post-operative

Other outcomes

Sponsors and contacts

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