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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilitary Hospital of Tunis

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Injectable Platelet-Rich Fibrin (I-PRF)

    Biological/Vaccine

    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/Surgery

    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/Surgery

    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.

Treatment groups

50 Participants
are divided into 4 treatment groups
Group A: I-PRFExperimental treatment 2 interventions
Group B: Povidone-IodineExperimental treatment 2 interventions
Group C: Diode LaserExperimental treatment 2 interventions
Group D: Saline ControlSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, 3 months, and 6 months
2

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.

Time frame
Baseline, 3 months, and 6 months
3

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.

Time frame
Baseline, 3 months, and 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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