Use of Injectable Extended Platelet-Rich Fibrin as a Local Drug Delivery in the Treatment of Stage II Periodontitis Patients

NCT07080294 | Completed

• 1 other identifier: A0401024OM
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to assess the clinical effectiveness of local delivery of injectable extended platelet-rich fibrin in subgingival application when used in conjunction with scaling and root planing (SRP) in the treatment of stage II periodontitis. The primary outcome includes the clinical attachment gain after 6 months, whereas the secondary outcomes include the changes of probing pocket depth, bleeding on probing percentage, plaque and gingival indices and the concentration of matrix metalloproteinase-8 (MMP-8) in gingival crevicular fluid (GCF) after 3 and 6 months.

Conditions

Periodontitis Stage II; Gingival Pocket

Keywords

eprf; periodontitis stage II; Alb prf; pocket; albumin; SRP; extended prf; extended platelet rich fibrin; gel

Outcome Measures

Primary Outcomes (1)

• clinical attachment gain

  Clinical Attachment Level (CAL) measured from the cementoenamel junction to the base of the gingival sulcus (RD+PD).

  6 months

Secondary Outcomes (4)

• Probing Depth (PD)

  6 months

• Plaque index (PI).

  6 months

• Gingival index

  6 months

• Bleeding on probing (BOP)

  6 months

Study Arms (3)

extended platelet rich fibrin injection in pocket

EXPERIMENTAL

Thorough periodontal mechanical debridement and injection of ePRF inside the assigned pockets will be performed for 15 patients of stage II periodontitis.

Other: extended platelet rich fibrin injection in pocket

albumin injection in pocket

EXPERIMENTAL

Scaling and root planing and injection of albumin gel alone inside the pockets will be performed for 15 patients of stage II periodontitis

Other: albumin injection in pocket

scaling and root planing

EXPERIMENTAL

Mechanical debridement alone will be performed for 15 patients with stage II periodontitis without injection of any material into the pockets.

Other: scaling and root planing

Interventions

extended platelet rich fibrin injection in pocket OTHER

Whole blood (10 mL) will be centrifuged at 700 g for 8 minutes. The upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet- poor plasma (PPP) will be collected in a syringe. then PPP will be heated in a heat block device at 75°C for 10 minutes and thereafter cooled to room temperature for approximately 2 minutes. An injectable albumin gel will then be prepared. Then the liquid platelet-rich layer (liquid-PRF) including the buffy coat layer with accumulated platelets and leukocytes, will be collected in a separate syringe. The albumin gel and native liquid PRF will then be thoroughly mixed by utilizing a female-female luer lock connector. Now injectable e-PRF in final form is ready to be used.

extended platelet rich fibrin injection in pocket

albumin injection in pocket OTHER

Whole blood (10 mL) will be centrifuged at 700 g for 8 minutes. The upper layer (yellow layer) shows the liquid plasma layer. The most upper layer of platelet- poor plasma (PPP) will be collected in a syringe. then PPP will be heated in a heat block device at 75°C for 10 minutes and thereafter cooled to room temperature for approximately 2 minutes. An injectable albumin gel will then be prepared.

albumin injection in pocket

scaling and root planing OTHER

removes plaque and calculus above and below the gumline using manual or ultrasonic instruments.

scaling and root planing

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with stage II Periodontitis (pocket depth ≤ 5mm and CAL = 3-4 mm).
• Age range (30-50) years.
• Good compliance with the plaque control instructions following initial therapy.
• Availability for follow- up and maintenance program.

You may not qualify if:

• Periodontitis patients with stage I, III and IV.
• Smoking.
• Systemic diseases which could influence the outcome of the therapy.
• Pregnant and lactating females.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, DK, 35516, Egypt

Location

MeSH Terms

Conditions

Periodontitis; Gingival Pocket

Interventions

Albumins; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingivitis; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 23, 2025
• Study Start: April 17, 2024
• Primary Completion: May 7, 2025
• Study Completion: June 17, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

EG (1)