Alb-PRF as an Adjunct to Nonsurgical Periodontal Therapy
ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHalil Ata BIÇAKÇIOĞLU
About this trial
Periodontitis is an inflammatory disease that damages the tissues supporting the teeth. Nonsurgical periodontal therapy is the standard initial treatment, but deep periodontal pockets may remain after treatment. Albumin platelet-rich fibrin (Alb-PRF) is an autologous material prepared from the participant's own blood and applied locally to support periodontal healing.
The main purpose of this study is to determine whether applying Alb-PRF into periodontal pockets in addition to nonsurgical periodontal therapy provides greater clinical improvement than nonsurgical periodontal therapy alone. The study will also evaluate whether the additional application of Alb-PRF affects the levels of selected bacteria associated with periodontitis.
This randomized split-mouth study will include 24 adults with periodontitis. In each participant, matched periodontal sites will be randomly assigned to receive either nonsurgical periodontal therapy alone or nonsurgical periodontal therapy followed by an intrapocket application of Alb-PRF. Clinical periodontal measurements will be recorded at baseline and at 1, 3, and 6 months. Subgingival plaque samples will be collected from the same sites at baseline and 30 days after treatment. The primary outcome is the reduction in periodontal probing depth from baseline to 3 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 65 years.
Diagnosis of periodontitis according to the 2017 classification of periodontal and peri-implant diseases and conditions.
Presence of at least two clinically comparable periodontal sites within the same mouth that are suitable for a split-mouth design.
Periodontal probing depth of 5 mm or greater at the sites selected for randomization.
Disqualifiers
Current smoking or smoking cessation within the previous 6 months.
Diabetes mellitus, uncontrolled hypertension, serious cardiovascular disease, autoimmune disease, liver failure, kidney failure, or another systemic condition that may adversely affect periodontal healing or treatment.
Use of antibiotics, corticosteroids, bisphosphonates, antiresorptive agents, immunosuppressive agents, or other medications known to affect periodontal healing within the previous 6 months.
Pregnancy or lactation.
Trial design
Design model
Parallel
Treatments tested in this trial
Nonsurgical Periodontal Therapy
Procedure/SurgeryNonsurgical periodontal therapy will include individualized oral hygiene instruction and supra- and subgingival mechanical debridement using periodontal hand instruments and/or ultrasonic devices. This intervention will be administered to the periodontal sites assigned to both study arms.
Albumin Platelet-Rich Fibrin
Other interventionAlb-PRF will be prepared under sterile conditions from autologous venous blood collected from each participant during the treatment visit. The albumin-containing plasma fraction will be heated at 75°C for 10 minutes and then combined with the appropriate liquid platelet-rich fibrin fraction to produce the Alb-PRF matrix. The freshly prepared Alb-PRF will be applied locally into the periodontal pocket immediately after nonsurgical periodontal therapy.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Nonsurgical Periodontal TherapyActive comparator 1 intervention
Group B: Nonsurgical Periodontal Therapy Plus Alb-PRFExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Periodontal Probing Depth
Periodontal probing depth (PPD) will be measured in millimeters using a periodontal probe at the randomized control and Alb-PRF-treated sites. PPD reduction will be calculated by subtracting the 3-month PPD value from the baseline PPD value. A higher positive value indicates a greater reduction in probing depth.
Time frame
Baseline to 3 monthsSecondary outcomes
1
Change in Clinical Attachment Level
Clinical attachment level (CAL) will be measured in millimeters using a periodontal probe at the randomized control and Alb-PRF-treated sites. CAL gain will be calculated by subtracting the follow-up CAL value from the baseline CAL value. A higher positive value indicates greater clinical attachment gain.
Time frame
Baseline to 3 and 6 months2
Change in Bleeding on Probing
Bleeding on probing (BOP) will be recorded as present or absent after gentle periodontal probing at the assessed sites. The result will be expressed as the percentage of sites showing bleeding, ranging from 0% to 100%. A lower percentage indicates less gingival inflammation.
Time frame
Baseline to 1, 3, and 6 months3
Change in Plaque Index
Plaque accumulation will be assessed using the Silness and Löe Plaque Index. Each assessed surface will be scored from 0 to 3, with higher scores indicating greater plaque accumulation. Changes in Plaque Index scores will be compared between the study arms over time.
Time frame
Baseline to 1, 3, and 6 months4
Change in Gingival Index
Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each assessed surface will be scored from 0 to 3, with higher scores indicating greater gingival inflammation. Changes in Gingival Index scores will be compared between the study arms over time.
Time frame
Baseline to 1, 3, and 6 monthsOther outcomes
1
Change in Porphyromonas gingivalis Bacterial Load
Subgingival plaque samples will be collected from the randomized control and Alb-PRF-treated sites. Porphyromonas gingivalis bacterial load will be quantified using quantitative real-time polymerase chain reaction and standard curves. The change from baseline to day 30 will be calculated and compared between the study arms.
Time frame
Baseline to 30 days2
Change in Aggregatibacter actinomycetemcomitans Bacterial Load
Subgingival plaque samples will be collected from the randomized control and Alb-PRF-treated sites. Aggregatibacter actinomycetemcomitans bacterial load will be quantified using quantitative real-time polymerase chain reaction and standard curves. The change from baseline to day 30 will be calculated and compared between the study arms.
Time frame
Baseline to 30 days3
Change in Prevotella intermedia Bacterial Load
Subgingival plaque samples will be collected from the randomized control and Alb-PRF-treated sites. Prevotella intermedia bacterial load will be quantified using quantitative real-time polymerase chain reaction and standard curves. The change from baseline to day 30 will be calculated and compared between the study arms.
Time frame
Baseline to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Halil Ata BIÇAKÇIOĞLU
Lead sponsor
Çankırı Karatekin University
Sponsor institution
Source ClinicalTrials.gov
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