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

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

Interventions

BIOLOGICAL

Injectable 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

DEVICE

Diode Laser Activation

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

DRUG

Povidone-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.

PROCEDURE

Saline 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.

PROCEDURE

Scaling 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.

Sponsors & Collaborators

• Military Hospital of Tunis

  lead OTHER

Principal Investigators

• Hela Jegham, DDS -Professor · Military Hospital of Instruction of Tunis

• hedi chouchene, DDS · Military Hospital of Instruction of Tunis

• Rym masmoudi, DDS - Associate Professor · Military Hospital of Instruction of Tunis

• yassmine rjeb, DDS · Military Hospital of Instruction of Tunis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-25

Primary Completion

2027-05-18

Completion

2027-05-18

Countries

• Tunisia

Study Locations