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NCT Number: NCT07707063

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Non Smokers Periodontal Disease Periodontal Diseases Periodontal Pocket Smokers Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Military Hospital of Instruction of Tunis

Tunis, Mont Fleury, 1008, Tunisia

Location status: Recruiting

Location contact

hedi chouchene, DDS

PRINCIPAL_INVESTIGATOR

hela Jegham, DDS - Professor

CONTACT

[email protected]

+216 54 241 521

yasmine rjab, DDS

PRINCIPAL_INVESTIGATOR

About this study

The investigators hypothesize that while all adjuncts will improve results over SRP and saline irrigation , the biological group (I-PRF) will show the most significant gains in the Smoker Subgroup due to its ability to stimulate local angiogenesis and tissue repair in a traditionally poor healing environment.

  • By including smokers, this study addresses "the down to reality " challenge in dentistry. Smoking often impairs the blood supply to the gums; this trial investigates: if a biological approach like I-PRF (which introduces fresh growth factors) or a high-volume Antiseptic irrigation with Povidone-iodine, or a 980nm diode laser activation can overcome these healing barriers . The Key Research Goals: is to determine if the Biological group (I-PRF), which introduces high concentrations of growth factors and leukocytes, provides superior Probing Pocket Depth (PPD) reduction compared to an antiseptic group (Povidone-Iodine) and photobiomodulation group (diode laser activation).
  • The Smoking Factor:

Investigator will explore if the regenerative properties of I-PRF can overcome the compromised healing response typically found in the Smoking Subgroup.

  • Healing Quality: Investigator will identify which group shows the fastest reduction in inflammation, measured by Bleeding on Probing (BOP) and Clinical Attachment Level (CAL) gain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion: Patients with Stage II-IV Periodontitis; at least one bleeding pocket > 4 mm minimum in every quadrant.

Exclusion: patients who:

  • 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

Treatment and study plan

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

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

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.

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.

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.

Primary outcomes

  1. Bleeding on Probing (BOP)

    Time frame: Baseline, 3 months, and 6 months

    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

  2. Probing Pocket Depth (PPD)

    Time frame: Baseline, 3 months, and 6 months

    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.

  3. Clinical Attachment Level (CAL)

    Time frame: Baseline, 3 months, and 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hela Jegham, DDS - Professor

CONTACT

[email protected]

+21654241521

hedi chouchene, DDS

CONTACT

[email protected]

+21652042177

Sponsors and collaborators

Lead sponsor

Military Hospital of Tunis

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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