Alb-PRF as an Adjunct to Nonsurgical Periodontal Therapy

NCT07794046 | Not Yet Recruiting

• 1 other identifier: ALBPRF-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontitis

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

Outcome Measures

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.

  Baseline to 3 months

Secondary Outcomes (6)

• Change in Clinical Attachment Level

  Baseline to 3 and 6 months

• Change in Bleeding on Probing

  Baseline to 1, 3, and 6 months

• Change in Plaque Index

  Baseline to 1, 3, and 6 months

• Change in Gingival Index

  Baseline to 1, 3, and 6 months

• Change in the Proportion of Sites With Periodontal Probing Depth of 5 mm or Greater

  Baseline to 3 and 6 months

Other Outcomes (3)

• Change in Porphyromonas gingivalis Bacterial Load

  Baseline to 30 days

• Change in Aggregatibacter actinomycetemcomitans Bacterial Load

  Baseline to 30 days

• Change in Prevotella intermedia Bacterial Load

  Baseline to 30 days

Study Arms (2)

Nonsurgical Periodontal Therapy

ACTIVE COMPARATOR

In each participant, the periodontal site randomly assigned to the control arm will receive standard nonsurgical periodontal therapy, including oral hygiene instruction and supra- and subgingival mechanical debridement. No additional intrapocket material will be applied to the control site.

Procedure: Nonsurgical Periodontal Therapy

Nonsurgical Periodontal Therapy Plus Alb-PRF

EXPERIMENTAL

In each participant, the matched periodontal site randomly assigned to the experimental arm will receive the same nonsurgical periodontal therapy as the control site, followed by the local intrapocket application of autologous albumin platelet-rich fibrin (Alb-PRF).

Procedure: Nonsurgical Periodontal Therapy; Other: Albumin Platelet-Rich Fibrin

Interventions

Nonsurgical Periodontal Therapy PROCEDURE

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.

Also known as: NSPT, Scaling and Root Planing, SRP

Nonsurgical Periodontal Therapy; Nonsurgical Periodontal Therapy Plus Alb-PRF

Albumin Platelet-Rich Fibrin OTHER

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.

Also known as: Alb-PRF, Albumin-Enriched Platelet-Rich Fibrin

Nonsurgical Periodontal Therapy Plus Alb-PRF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halil Ata BIÇAKÇIOĞLU: lead

Study Sites (2)

Gazi University Faculty of Dentistry, Department of Periodontology

Ankara, Ankara, 06490, Turkey (Türkiye)

Location

Çankırı Karatekin University Faculty of Dentistry, Department of Periodontology

Çankırı, Çankırı, 18100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Halil Ata Bıçakçıoğlu, PhD

  Çankırı Karatekin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halil Ata Bıçakçıoğlu, PhD

CONTACT

+903762189578; halilbicakcioglu@karatekin.edu.tr

Gülenay Çolak, DDS

CONTACT

+093122034000; gulenaycolak@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication of the study results and will remain available for 5 years.
• Access Criteria: Data may be provided to qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the principal investigator and the relevant institution. Data will be shared for approved scientific purposes following ethics and institutional requirements and, where applicable, execution of a data use agreement.

Locations

TU (2)