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 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
50
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Hela Jegham, DDS - Professor
- Telefonnummer: +21654241521
- E-Mail: hela.jegham@yahoo.fr
Studieren Sie die Kontaktsicherung
- Name: hedi chouchene, DDS
- Telefonnummer: +21652042177
- E-Mail: chouchanehadi76@gmail.com
Studienorte
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Mont Fleury
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Tunis, Mont Fleury, Tunesien, 1008
- Rekrutierung
- Military Hospital of Instruction of Tunis
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Kontakt:
- hela Jegham, DDS - Professor
- Telefonnummer: +216 54 241 521
- E-Mail: hela.jegham@yahoo.fr
-
Hauptermittler:
- hedi chouchene, DDS
-
Hauptermittler:
- yasmine rjab, DDS
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: I-PRF
Quadrants randomly assigned to receive I-PRF irrigation after SRP
|
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
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.
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|
Experimental: Povidone-Iodine
Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP
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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.
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.
|
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Experimental: Diode Laser
Quadrants randomly assigned to receive diode laser activation after SRP
|
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.
Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol
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Schein-Komparator: Saline Control
Quadrants randomly assigned to receive 0.9% saline irrigation after SRP
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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.
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Bleeding on Probing (BOP)
Zeitfenster: 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
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Baseline, 3 months, and 6 months
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Probing Pocket Depth (PPD)
Zeitfenster: 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.
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Baseline, 3 months, and 6 months
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Clinical Attachment Level (CAL)
Zeitfenster: Baseline, 3 months, and 6 months
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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.
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Baseline, 3 months, and 6 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Hela Jegham, DDS -Professor, Military Hospital of Instruction of Tunis
- Hauptermittler: hedi chouchene, DDS, Military Hospital of Instruction of Tunis
- Studienleiter: Rym masmoudi, DDS - Associate Professor, Military Hospital of Instruction of Tunis
- Hauptermittler: yassmine rjeb, DDS, Military Hospital of Instruction of Tunis
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
25. Mai 2026
Primärer Abschluss (Geschätzt)
18. Mai 2027
Studienabschluss (Geschätzt)
18. Mai 2027
Studienanmeldedaten
Zuerst eingereicht
22. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. Juli 2026
Zuerst gepostet (Tatsächlich)
16. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Mundkrankheiten
- Stomatognathe Erkrankungen
- Parodontitis
- Parodontale Erkrankungen
- Parodontale Tasche
- Verdauungssystem und orale physiologische Phänomene
- Zahnheilkunde
- Zahnärztliche physiologische Phänomene
- Zahnärztliche Skalierung
- Zahnprophylaxe
- Parodontie
- Subgingival Curettage
- Präventive Zahnmedizin
- Proliferationsregulierungsfaktoren, menschlicher Urin
- Wurzelplanung
- Zahnpeeling
Andere Studien-ID-Nummern
- MilitaryHosp Tunis
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Beginning 6 months after publication of the primary study results and ending 5 years after publication.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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