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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

10. juli 2026 opdateret af: Hela Jegham, Military Hospital of Tunis

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tunesien
    • Mont Fleury
      • Tunis, Mont Fleury, Tunesien, 1008
        • Rekruttering
        • Military Hospital of Instruction of Tunis
        • Kontakt:
        • Ledende efterforsker:
          • hedi chouchene, DDS
        • Ledende efterforsker:
          • yasmine rjab, DDS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: I-PRF
Quadrants randomly assigned to receive I-PRF irrigation after SRP
Biologisk: 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
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.
Eksperimentel: Povidone-Iodine
Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP
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.
Medicin: 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.
Eksperimentel: Diode Laser
Quadrants randomly assigned to receive diode laser activation after SRP
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.
Enhed: 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
Sham-komparator: Saline Control
Quadrants randomly assigned to receive 0.9% saline irrigation after SRP
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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bleeding on Probing (BOP)
Tidsramme: 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
Baseline, 3 months, and 6 months
Probing Pocket Depth (PPD)
Tidsramme: 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.
Baseline, 3 months, and 6 months
Clinical Attachment Level (CAL)
Tidsramme: 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.
Baseline, 3 months, and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Military Hospital of Tunis

Efterforskere

  • Studieleder: Hela Jegham, DDS -Professor, Military Hospital of Instruction of Tunis
  • Ledende efterforsker: hedi chouchene, DDS, Military Hospital of Instruction of Tunis
  • Studieleder: Rym masmoudi, DDS - Associate Professor, Military Hospital of Instruction of Tunis
  • Ledende efterforsker: yassmine rjeb, DDS, Military Hospital of Instruction of Tunis

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. maj 2026

Primær færdiggørelse (Anslået)

18. maj 2027

Studieafslutning (Anslået)

18. maj 2027

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

16. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MilitaryHosp Tunis

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

identified individual participant data collected during the study will be shared, including demographic characteristics (age and sex), smoking status, baseline and follow-up periodontal measurements, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), treatment allocation by quadrant, and outcome data used in the primary and secondary analyses.

IPD-delingstidsramme

Beginning 6 months after publication of the primary study results and ending 5 years after publication.

IPD-delingsadgangskriterier

qualified researchers who provide a methodologically sound research proposal. Requests should be submitted to the principal investigator and will be reviewed in accordance with institutional policies, ethical requirements, and participant confidentiality protections.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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