The Effectiveness of Root Planing and Injectable Platelet-Rich Fibrin in Smoking Patients With Periodontitis

NCT07049549 | Completed

• 1 other identifier: 2020-KAE-0072
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a chronic, multifactorial inflammatory disease characterized by the progressive destruction of the tissues supporting the teeth, associated with dysbiotic plaque biofilms. The foundation of non-surgical periodontal treatment is the mechanical debridement of the tooth surfaces to reduce bacterial load. In this phase, dental calculus and bacterial deposits are removed, and root surfaces are smoothened. This helps eliminate the microorganisms responsible for inflammation. Following treatment, epithelial healing occurs in the form of long epithelial attachment, which re-forms within approximately one week. The reduction of inflammatory cells, tissue repair, and decreased gingival crevicular fluid flow lead to the resolution of clinical signs such as redness and swelling. A tissue recession of 1-2 mm is generally observed. The fibrils in the connective tissue are altered or lysed during the disease process, and their reorganization and healing may take several weeks. The aim of this study is to evaluate the clinical effects (plaque index, gingival index, bleeding on probing, probing pocket depth, clinical attachment level) of injectable platelet-rich fibrin (I-PRF) in addition to non-surgical periodontal treatment in periodontitis patients with deep pockets and smoking habits. In advanced cases, surgical treatments may be required. According to the study by Heitz-Mayfield and colleagues, surgical treatment in pockets deeper than 6 mm resulted in a 0.6 mm greater reduction in probing depth and 0.2 mm more clinical attachment gain compared to scaling and root planing alone. However, for pockets between 4-6 mm in depth, non-surgical treatment resulted in 0.4 mm more attachment gain compared to surgical procedures. In a systematic review by Labriola and colleagues, it was found that smokers had a lesser reduction in pocket depth. Furthermore, Scabbia and colleagues reported that smokers had significantly lower clinical improvements after surgical treatment. Smoking negatively affects healing, and factors such as exposed root surfaces and protected areas for residual plaque contribute to disease recurrence. Long-term studies have shown that smokers experience higher tooth loss. The use of blood-derived products in wound healing started 40 years ago, with fibrin adhesives standing out. Fibrin is the activated form of fibrinogen, a plasma molecule, and is the final product of coagulation. Polymerized fibrin forms the initial scar matrix in the wound area, serving as a biological adhesive that aids in hemostasis. One of the most commonly used blood-derived products in dentistry is platelet-rich fibrin (PRF). Developed by Choukroun in 2001, this second-generation product can be prepared without anticoagulants, thrombin, or gelling agents. It is a simple and cost-effective method. Injectable PRF (I-PRF) is obtained by altering the centrifugation speed and duration. Miron and colleagues demonstrated that low-speed I-PRF contains a higher number of regenerative cells and growth factors. A study by Kour and colleagues showed that I-PRF has antimicrobial effects against periodontal pathogens such as Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. In conclusion, I-PRF, prepared from the patient's own blood, may provide biological support to non-surgical periodontal treatment, positively influencing the healing process and reducing the need for surgical interventions. The aim of this study is to assess the clinical effects (plaque index, gingival index, bleeding on probing, pocket depth, clinical attachment level) of I-PRF in conjunction with non-surgical periodontal treatment in periodontitis patients with deep pockets and smoking habits. A total of 25 volunteers will be included in the study. Inclusion criteria are: not pregnant, no use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids, no periodontal treatment in the past 6 months, presence of at least 20 teeth, bleeding on probing in ≥30% of sites, and at least two non-adjacent teeth in each quadrant with probing depth ≥5 mm, clinical attachment loss ≥4 mm, and radiographic evidence of bone loss in the coronal third (horizontal and/or vertical). Informed consent will be obtained after explaining the study. Eligible participants will undergo clinical periodontal evaluation including plaque index (Silness \& Löe, 1964), gingival index (Löe \& Silness, 1963), probing depth, clinical attachment loss, and bleeding on probing (Ainamo \& Bay, 1975). At the second visit, full-mouth scaling and root planing will be performed. In the test sites, injectable platelet-rich fibrin (I-PRF), prepared by centrifugation at 700 rpm for 3 minutes, will be applied. Control sites will receive saline without antimicrobial or regenerative effects. Follow-ups for oral hygiene reinforcement will be scheduled at 1 week, 1 month, and 3 months. Clinical measurements will be repeated at 3 months.

Conditions

Periodontal Healing; Periodontitis; i-PRF

Keywords

i-prf; periodontitis; root planing; platelet-rich fibrin; periodontal debridement

Outcome Measures

Primary Outcomes (2)

• The evaluation of changes in Probing Pocket Depth (PPD)

  Probing Pocket Depth (PPD) measurements are take at baseline (first session) and at the 3-month follow-up to assess clinical changes over time. Using a periodontal probe, the distance between the gingival margin and the base of the sulcus or periodontal pocket is measured at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, midpalatal/lingual, and distopalatal/lingual. Care is taken to keep the probe parallel to the long axis of the tooth and to apply minimal force during measurement. The values from the six sites are summed and divided by six to calculate the average PPD.

  Baseline and 3 months

• The evaluation of changes in Clinical Attachment Levels (CAL)

  CAL measurements are taken at baseline (first session) and at the 3-month follow-up to assess clinical changes over time. Using a periodontal probe, the distance between the enamel-cement junction and the base of the sulcus or periodontal pocket is measured at six sites per tooth: mesiobuccal, midbuccal, distobuccal, mesiopalatal/lingual, midpalatal/lingual, and distopalatal/lingual. The values from these six points are summed and divided by six to calculate the average clinical attachment level.

  Baseline and 3 months

Study Arms (2)

Test Group

ACTIVE COMPARATOR

Subjects would receive full-mouth scaling and root planing (SRP). Following instrumentation, autologous injectable platelet-rich fibrin (i-PRF) will be prepared from venous blood and administered subgingivally to the test quadrants according to a split-mouth design.

Biological: Injectable PRF

Control Group

PLACEBO COMPARATOR

Subjects will be receive full-mouth scaling and root planing (SRP). Following instrumentation, placebo (sterile saline) is administered subgingivally to the control quadrants according to a split-mouth design.

Other: Plasebo (Sterile Saline)

Interventions

Injectable PRF BIOLOGICAL

Autologous injectable platelet-rich fibrin (i-PRF) will be prepared from venous blood using low-speed centrifugation and administered subgingivally to the test quadrants following full-mouth scaling and root planing.

Test Group

Plasebo (Sterile Saline) OTHER

sterile saline solution will be administered subgingivally to the control quadrants following full-mouth scaling and root planing (SRP).

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 70 years
• Having at least 20 natural teeth
• Presence of interproximal CAL and/or buccal or lingual CAL ≥3 mm accompanied by PPD \>3 mm in at least two non-adjacent teeth
• Presence of periodontal pockets ≥4 mm in at least one site in each dental arch
• Smoking more than 10 cigarettes per day
• Absence of systemic diseases or ongoing medication use
• No antibiotic, anti-inflammatory, or systemic corticosteroid use within the last 6 months
• No periodontal treatment within the last 6 months
• Not pregnant, lactating, or menstruating

You may not qualify if:

• presence of systemic or oral diseases
• regular systemic medication use
• recent periodontal or pharmacological treatment history
• hormonal conditions.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

İzmir Katip Çelebi University, Faculty of Dentistry, Department of Periodontology

Izmir, Çiğli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: A split-mouth design will be used. Each subject would receive both interventions in selected (randomized) quadrants.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 15, 2020
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)