This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients

NCT07707063 | Recruiting Phase 4 DMC

• 1 other identifier: MilitaryHosp Tunis
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit. The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP/EFP periodontal classification.

Conditions

Periodontitis; Smokers; Non Smokers; Periodontal Disease

Keywords

Injectable platelet-rich fibrin (I-PRF); Diode Laser; iodine solution; Periodontal Pockets; periodontal debridement; lasers; Regenerative periodontal therapy

Outcome Measures

Primary Outcomes (3)

• Bleeding on Probing (BOP)

  Bleeding on Probing (BOP) will be assessed within 15 seconds after gentle probing at six sites per tooth using a calibrated periodontal probe ( The instrument used (UNC-15 periodontal probe). The presence or absence of bleeding will be recorded and expressed as the percentage of bleeding sites per treatment quadrant. Measurements will be obtained by a blinded examiner at baseline, 3 months, and 6 months

  Baseline, 3 months, and 6 months

• Probing Pocket Depth (PPD)

  Probing Pocket Depth (PPD) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual/palatal, midlingual/palatal, and distolingual/palatal). Measurements will be performed by a calibrated examiner blinded to treatment allocation at baseline, 3 months, and 6 months.

  Baseline, 3 months, and 6 months

• Clinical Attachment Level (CAL)

  Clinical Attachment Level (CAL) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth by measuring the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. Assessments will be performed by a blinded calibrated examiner at baseline, 3 months, and 6 months.

  Baseline, 3 months, and 6 months

Study Arms (4)

I-PRF

EXPERIMENTAL

Quadrants randomly assigned to receive I-PRF irrigation after SRP

Biological: Injectable Platelet-Rich Fibrin (I-PRF); Procedure: Scaling and Root Planing

Povidone-Iodine

EXPERIMENTAL

Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP

Drug: Povidone-Iodine Irrigation (1%); Procedure: Scaling and Root Planing

Diode Laser

EXPERIMENTAL

Quadrants randomly assigned to receive diode laser activation after SRP

Device: Diode Laser Activation; Procedure: Scaling and Root Planing

Saline Control

SHAM COMPARATOR

Quadrants randomly assigned to receive 0.9% saline irrigation after SRP

Procedure: Saline Irrigation (0.9%); Procedure: Scaling and Root Planing

Interventions

Injectable Platelet-Rich Fibrin (I-PRF) BIOLOGICAL

Following scaling and root planing, periodontal pockets in the assigned quadrant will receive 5 mL of injectable platelet-rich fibrin (I-PRF) prepared at 60 G for 3 minutes

I-PRF

Diode Laser Activation DEVICE

Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol

Diode Laser

Povidone-Iodine Irrigation (1%) DRUG

Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of 1% povidone iodine solution delivered using a blunt-tip cannula.

Povidone-Iodine

Saline Irrigation (0.9%) PROCEDURE

Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of sterile 0.9% saline solution delivered using a blunt-tip cannula. This intervention serves as the control treatment for comparison with the adjunctive therapies.

Saline Control

Scaling and Root Planing PROCEDURE

Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments. All study quadrants will receive SRP before adjunctive treatment allocation.

Diode Laser; I-PRF; Povidone-Iodine; Saline Control

Eligibility Criteria

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

You may not qualify if:

• Pregnant /Lactating
• History of radiotherapy or chemotherapy in the head/neck region.
• Known hypersensitivity to Iodine or Methylene blue solution
• Systematic antibiotic use within the last 30 days
• Long-term use of immunosuppressants or corticosteroids (daily use)
• type 1 / 2 diabetes

Sponsors & Collaborators

• Military Hospital of Tunis: lead

Study Sites (1)

Military Hospital of Instruction of Tunis

Tunis, Mont Fleury, 1008, Tunisia

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Periodontal Pocket

Interventions

proliferation regulatory factors, human urine; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

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

• Hela Jegham, DDS -Professor

  Military Hospital of Instruction of Tunis

  STUDY DIRECTOR

• hedi chouchene, DDS

  Military Hospital of Instruction of Tunis

  PRINCIPAL INVESTIGATOR

• Rym masmoudi, DDS - Associate Professor

  Military Hospital of Instruction of Tunis

  STUDY DIRECTOR

• yassmine rjeb, DDS

  Military Hospital of Instruction of Tunis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hela Jegham, DDS - Professor

CONTACT

+21654241521; hela.jegham@yahoo.fr

hedi chouchene, DDS

CONTACT

+21652042177; chouchanehadi76@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Surgery - Professor at Military Hospital of Instruction of Tunis

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 16, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 18, 2027
• Study Completion (Estimated): May 18, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication of the primary study results and ending 5 years after publication.
• Access Criteria: qualified researchers who provide a methodologically sound research proposal. Requests should be submitted to the principal investigator and will be reviewed in accordance with institutional policies, ethical requirements, and participant confidentiality protections.

Locations

TU (1)