RecruitingPhase 4NCT07707063

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

Clinical Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients : A Split Mouth Randomized Clinical Trial


Sponsor

Military Hospital of Tunis

Enrollment

50 participants

Start Date

May 25, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Exclusion Criteria6

  • 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

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Interventions

BIOLOGICALInjectable Platelet-Rich Fibrin (I-PRF)

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

DEVICEDiode Laser Activation

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

DRUGPovidone-Iodine Irrigation (1%)

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.

PROCEDURESaline Irrigation (0.9%)

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.

PROCEDUREScaling and Root Planing

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.


Locations(1)

Military Hospital of Instruction of Tunis

Tunis, Mont Fleury, Tunisia

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NCT07707063


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