Alb-PRF as an Adjunct to Nonsurgical Periodontal Therapy

Clinical and Microbiological Effects of Intrapocket Albumin Platelet-Rich Fibrin as an Adjunct to Nonsurgical Periodontal Therapy: A Randomized Split-Mouth Clinical 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.

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.

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.