The Effect of I-PRF As An Adjunct to Non-Surgical Periodontal Therapy on Clinical Parameters in Smokers With Periodontitis

NCT06605547 | Completed

• 1 other identifier: BAIBU-SBF-BMY-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to evaluate the effect of subgingival injectable platelet-rich fibrin (i-PRF) application on clinical periodontal parameters as an adjunct to non-surgical periodontal treatment (NSPT) in smokers with periodontitis. Twenty-five systemically healthy, smoker patients with stage II/III periodontitis were included in the study. In this split-mouth trial, subgingival i-PRF was applied to the test group in addition to NSPT, while saline was applied to the control group after NSPT. Subgingival i-PRF/saline application was repeated on the 7th day in both groups. Clinical periodontal parameters were recorded at baseline, 1st and 3rd months after the treatment.

Conditions

Periodontitis

Keywords

smoker; periodontitis; i-PRF

Outcome Measures

Primary Outcomes (2)

• Clinical attachment loss (CAL)

  CAL measured as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus (the most coronal attachment) using a Williams periodontal probe. The changes in clinical attachment loss was measured for determining the severity of disease.

  Baseline, 1st and 3rd months

• Probing pocket depth (PPD)

  PPD measured as the change in distance from the gingival margin to the bottom of the gingival sulcus using a Williams periodontal probe. The changes in PPD was measured for determining of the severity of disease and clinical outcome.

  Baseline, 1st and 3rd months

Secondary Outcomes (3)

• Bleeding on probing (BOP)

  Baseline, 1st and 3rd months

• Turesky Modified Quigley-Hein Plaque Index (TQHPI)

  Baseline, 1st and 3rd months

• Gingival index (GI)

  Baseline, 1st and 3rd months

Study Arms (2)

Test group

ACTIVE COMPARATOR

Test sites receiving the subgingival application of i-PRF after NSPT.

Procedure: Non-surgical periodontal treatment; Other: Subgingival application of i-PRF

Control group

PLACEBO COMPARATOR

Control sites treated with saline after NSPT.

Procedure: Non-surgical periodontal treatment; Device: Subgingival application of saline

Interventions

Non-surgical periodontal treatment PROCEDURE

The non-surgical periodontal treatment (scaling and root planing) was applied under local anesthesia using ultrasonic device and Gracey curettes. After scaling and root planing, periodontal pockets were irrigated using saline solution. Non-surgical periodontal treatment was completed in one or two sessions within 24 hours.

Control group; Test group

Subgingival application of saline DEVICE

For the subgingival saline application at the control sites, the insulin needle was filled with saline and the 29-gauge needle tip was gently placed into the periodontal pocket. The saline was injected into the periodontal pocket until it was seen to overflow from the gingival margin. Subgingival saline application was repeated on the 7th day.

Control group

Subgingival application of i-PRF OTHER

For subgingival application of i-PRF at the test sites, the i-PRF taken into the insulin syringe, the 29-gauge needle tip was gently placed into the periodontal pocket and the i-PRF was injected into the periodontal pocket until it reached the gingival margin (until it overflowed from the sulcus). Subgingival i-PRF application was repeated on the 7th day.

Test group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients were systemically healthy adults,
• having at least 20 natural teeth,
• the presence of contralateral periodontal pockets (PPD≥ 5 mm) and CAL≥2 mm on a minimum of two premolar/molar teeth on each side and no furcation involvement,
• smoking more than 10 cigarettes per day for at least 5 years,
• stage II-III periodontitis patients

You may not qualify if:

• individuals had past periodontal treatment within 6 months
• individuals had used systemic antibiotics in the last 6 months or anti- inflammatory drugs in the last 3 months before the beginning of the trial,
• patient with clotting and hematologic disorders, had used drugs affecting the natural coagulation process,
• patients taking medications that affect the gingival and periodontal tissues
• pregnant or breastfeeding females

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

Location

Related Publications (1)

• Cagiran Gurbuz T, Meraci Yildiran B. The clinical efficacy of injectable platelet-rich fibrin (i-PRF) as an adjunct to nonsurgical periodontal therapy in smokers with periodontitis. BMC Oral Health. 2025 Apr 23;25(1):618. doi: 10.1186/s12903-025-06019-w.

  PMID: 40269777 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Split-mouth, randomized controlled

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: September 4, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)