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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Injectable Platelet-Rich Fibrin (I-PRF), Diode Laser Activation, Povidone-Iodine Irrigation (1%), Saline Irrigation (0.9%).
- Who it may be relevant to
- Registry conditions: Periodontitis, Smokers, Non Smokers, Periodontal Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Bleeding on Probing (BOP) [Time frame: Baseline, 3 months, and 6 months]
- Probing Pocket Depth (PPD) [Time frame: Baseline, 3 months, and 6 months]
- Clinical Attachment Level (CAL) [Time frame: Baseline, 3 months, and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Tunisia · 1 center
- Military Hospital of Instruction of Tunis — Tunis
Identifiers
NCT: NCT07707063 · MilitaryHosp Tunis