Periodontitis
Conditions
Keywords
Albumin Platelet-Rich Fibrin, Alb-PRF, Nonsurgical Periodontal Therapy, Scaling and Root Planing, Intrapocket Application, Periodontal Pocket, Autologous Platelet Concentrate, Split-Mouth Clinical Trial, Subgingival Microbiota, Quantitative Real-Time PCR, Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Prevotella intermedia
Brief summary
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.
Detailed description
This study is designed as a multicenter, randomized, controlled, split-mouth clinical trial with a single-masked outcome assessment. A total of 24 adults with periodontitis and at least two clinically comparable periodontal sites suitable for a split-mouth comparison will be enrolled. Within each participant, eligible periodontal sites will be randomly assigned to a control or test condition. Control sites will receive standard nonsurgical periodontal therapy, including oral hygiene instruction and supra- and subgingival mechanical debridement. Test sites will receive the same nonsurgical periodontal therapy followed by the local application of Alb-PRF into the periodontal pocket. Alb-PRF will be prepared from the participant's own venous blood under sterile conditions during the treatment visit. Clinical periodontal assessments will be performed at baseline and at 1, 3, and 6 months. The clinical variables will include periodontal probing depth, clinical attachment level, bleeding on probing, plaque index, and gingival index. The examiner performing the clinical measurements will be masked to the site allocation. The primary outcome measure will be the change in periodontal probing depth from baseline to 3 months. An integrated microbiological assessment will be conducted in the same participants, without enrolling a separate study population. Subgingival plaque samples will be collected from the randomized control and test sites at baseline and 30 days after treatment. The bacterial loads of Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, and Prevotella intermedia will be measured using quantitative real-time polymerase chain reaction. Changes in bacterial load between baseline and day 30 will be evaluated as exploratory outcomes and compared between the control and Alb-PRF-treated sites.
Interventions
PROCEDURENonsurgical Periodontal Therapy
Nonsurgical 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.
Alb-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.
Sponsors
Halil Ata BIÇAKÇIOĞLU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The examiner performing the clinical periodontal measurements will be masked to site allocation. Microbiological analyses will be performed using coded samples, and the laboratory personnel will remain unaware of the treatment allocation until the analyses have been completed. The clinician performing the interventions cannot be masked.
Intervention model description
This is a randomized split-mouth study. Within each participant, two clinically comparable periodontal sites will be assigned to the two intervention arms. One site will receive nonsurgical periodontal therapy alone, while the matched site will receive the same therapy followed by intrapocket Alb-PRF application. Both interventions will be administered during the same treatment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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. * No systemic condition that would contraindicate nonsurgical periodontal therapy or adversely affect periodontal healing. * No current use of medications known to affect periodontal tissue healing. * No periodontal surgical treatment within the previous 6 months. * Ability to understand the study procedures, provide written informed consent, and attend the scheduled follow-up visits.
Exclusion criteria
* 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. * Acute periodontal abscess or acute endodontic infection at a selected study site. * Hematologic disease, bleeding disorder, anticoagulant therapy, or another condition that may interfere with venous blood collection. * Known hypersensitivity to any material used in the study. * Inadequate oral hygiene or inability to meet the oral hygiene requirements of the study protocol. * Current orthodontic treatment. * Inability or unwillingness to attend the scheduled follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Periodontal Probing Depth | Baseline to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level | Baseline to 3 and 6 months | 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. |
| Change in Bleeding on Probing | Baseline to 1, 3, and 6 months | 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. |
| Change in Plaque Index | Baseline to 1, 3, and 6 months | 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. |
| Change in Gingival Index | Baseline to 1, 3, and 6 months | 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. |
| Change in the Proportion of Sites With Periodontal Probing Depth of 5 mm or Greater | Baseline to 3 and 6 months | The proportion of randomized periodontal sites with a periodontal probing depth of 5 mm or greater will be calculated for each study arm. The result will be expressed as a percentage ranging from 0% to 100%. A lower percentage at follow-up indicates a reduction in the number of residual deep periodontal sites. |
| Number of Participants With Alb-PRF-Related Local Adverse Events | From intervention administration through 6 months | Participants will be assessed for local adverse events potentially related to intrapocket Alb-PRF application, including pain, tenderness, swelling, infection, and other unexpected local reactions. The occurrence and nature of each event will be recorded at treatment and follow-up visits. |
Countries
Turkey (Türkiye)
Contacts
CONTACTHalil Ata Bıçakçıoğlu, PhD
CONTACTGülenay Çolak, DDS
PRINCIPAL_INVESTIGATORHalil Ata Bıçakçıoğlu, PhD
Çankırı Karatekin University
Outcome results
None listed