Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Molecular and Clinical Evaluation of the Effects of Antimicrobial Photodynamic Therapy Applied Using Different Activation Techniques on the Microbiota and Host Response in Previously Root Canal-Treated Teeth With Apical Periodontitis
This randomized clinical trial aims to investigate the effects of different intracanal methylene blue agitation techniques used during antimicrobial photodynamic therapy (aPDT) on root canal microbiota, host inflammatory responses, postoperative pain, and periapical healing in previously root canal-treated teeth with asymptomatic apical periodontitis.
A total of 60 participants will be randomly allocated to four groups (15 participants per group): aPDT without additional methylene blue agitation (control), aPDT with standard needle irrigation(SNI), aPDT with passive ultrasonic irrigation (PUI), and aPDT with Er,Cr:YSSG laser-assisted irrigation (LAI).
All participants will undergo nonsurgical root canal retreatment. Methylene blue will be used as the photosensitizing agent, and photodynamic light irradiation will be performed using the LED FotoSan device in all groups.
Root canal samples will be collected at three treatment stages to investigate changes in microbial communities and inflammatory markers. Shotgun metagenomic sequencing will be performed in a subset of participants, while selected inflammatory cytokines will be measured using enzyme-linked immunosorbent assay (ELISA).
Postoperative pain and radiographic periapical healing will also be evaluated during follow-up.
The study aims to determine whether different methylene blue agitation techniques influence the microbiological, inflammatory, and clinical outcomes of antimicrobial photodynamic therapy during root canal retreatment.
Przegląd badań
Status
Szczegółowy opis
This randomized clinical trial will investigate the molecular, microbiological, inflammatory, and clinical effects of different intracanal methylene blue agitation techniques used during antimicrobial photodynamic therapy (aPDT) in previously root canal-treated permanent teeth with asymptomatic apical periodontitis.
A total of 60 participants will be randomly allocated to four groups (n=15 per group):
Control group: aPDT without additional intracanal methylene blue agitation.
Standard needle irrigation (SNI) group: aPDT with conventional syringe agitation of methylene blue.
Passive ultrasonic irrigation (PUI) group: aPDT with passive ultrasonic agitation of methylene blue.
Laser-activated irrigation (LAI) group: aPDT with Er,Cr:YSSG laser-assisted agitation of methylene blue.
All participants will undergo nonsurgical root canal retreatment, including removal of the previous root canal filling material and chemomechanical preparation. Methylene blue will be introduced into the root canal system as the photosensitizing agent. The assigned intracanal agitation protocol will then be performed, followed by photodynamic light irradiation using the FotoSan device in all groups.
Root canal samples will be collected at three stages: S1, after removal of the previous root canal filling material; S2, after chemomechanical preparation; and S3, following antimicrobial photodynamic therapy.
Shotgun metagenomic sequencing will be performed in a subset of 24 participants, including eight participants from each of the SNI, PUI, and LAI groups. The analysis will investigate microbial taxonomic composition, microbial diversity, functional pathways, antimicrobial resistance genes, and virulence-associated factors.
Host inflammatory responses will be evaluated in all four study groups by measuring interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α) using enzyme-linked immunosorbent assay (ELISA).
Postoperative pain will be assessed using a visual analog scale (VAS) at predefined intervals following treatment. Periapical healing will be evaluated radiographically during the follow-up period.
Within-group changes across sampling points and between-group differences will be evaluated to determine the influence of intracanal methylene blue agitation techniques on microbial communities, host inflammatory responses, postoperative pain, and periapical healing
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nihan Çelik Uzun, Assistant Professor
- Numer telefonu: +90 4623774813 +90 5557256407
- E-mail: nihancelik@ktu.edu.tr
Lokalizacje studiów
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Ortahisar
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Trabzon, Ortahisar, Turcja (Türkiye)
- Rekrutacyjny
- Karadeniz Technical University Faculty of Dentistry
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Kontakt:
- Nihan Çelik Uzun, Assistant Professor
- Numer telefonu: +90 5557256407
- E-mail: nihancelik@ktu.edu.tr
-
Główny śledczy:
- Nihan ÇELİK UZUN, Assistant Professor
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Adults aged 18-65 years.
- No history of systemic disease.
- Non-smokers.
- Not pregnant or breastfeeding.
- Provision of written informed consent.
- Willingness to attend follow-up appointments for 12 months
Exclusion Criteria:
- Teeth with internal or external root resorption.
- Teeth with moderate or severe root canal curvature.
- Teeth with open apices.
- Teeth with periodontal probing depths ≥4 mm.
- Teeth in which adequate rubber dam isolation cannot be achieved.
- Teeth considered non-restorable.
- Teeth requiring post retention.
- Teeth with radiographically determined periapical lesions larger than 5.
- Systemic antibiotic or anti-inflammatory medication use within the preceding month.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Control - aPDT Without Additional Activation
Participants will receive antimicrobial photodynamic therapy using methylene blue without additional intracanal agitation, followed by FotoSan light irradiation |
All participants will receive antimicrobial photodynamic therapy (aPDT) using methylene blue as the photosensitizer, followed by photodynamic light irradiation with the FotoSan device. The groups will differ according to the intracanal activation technique applied to methylene blue. |
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Eksperymentalny: Standard Needle Irrigation (SNI)
Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal agitation of methylene blue using a standard irrigation needle with back-and-forth movements, followed by photodynamic light irradiation using the FotoSan device. |
Methylene blue will be agitated within the root canal using a standard irrigation needle with back-and-forth movements before photodynamic light irradiation with the FotoSan device. |
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Eksperymentalny: Passive Ultrasonic Irrigation (PUI)
Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal activation of methylene blue using passive ultrasonic irrigation, followed by photodynamic light irradiation using the FotoSan device. |
Methylene blue will be activated within the root canal using passive ultrasonic irrigation before photodynamic light irradiation with the FotoSan device. |
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Eksperymentalny: Laser-Activated Irrigation (LAI)
Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal activation of methylene blue using an Er, Cr:YSGG laser-assisted irrigation technique, followed by photodynamic light irradiation using the FotoSan device |
ethylene blue will be activated within the root canal using an Er,Cr:YSGG laser-assisted irrigation technique before photodynamic light irradiation with the FotoSan device |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)
Ramy czasowe: Up to 7 days after treatment (24 hours, 72 hours, and day 7)
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Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain). Participants will record their pain intensity at 24 hours, 72 hours, and 1 week after treatment. Mean VAS scores at each time point will be compared among the four treatment groups. |
Up to 7 days after treatment (24 hours, 72 hours, and day 7)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Periapical Radiographic Healing Assessed Using the Periapical Index (PAI)
Ramy czasowe: From baseline through 12 months after treatment (baseline, immediately post-treatment, month 6, and month 12)
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Periapical radiographic healing will be assessed using digital periapical radiographs obtained with the paralleling technique. Periapical status will be evaluated using the Periapical Index (PAI), scored from 1 (normal periapical structures) to 5 (severe periodontitis with exacerbating features). Teeth with PAI scores of 1 or 2 will be classified as healed, whereas teeth with PAI scores of 3, 4, or 5 will be classified as not healed. Changes in PAI scores will be evaluated over time and compared among treatment groups. Periapical healing will be assessed using the Periapical Index (PAI) before treatment, immediately after treatment, and at 6 and 12 months after treatment. |
From baseline through 12 months after treatment (baseline, immediately post-treatment, month 6, and month 12)
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in Root Canal Microbial Composition
Ramy czasowe: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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hanges in root canal microbial composition will be assessed using shotgun metagenomic sequencing of samples collected at three treatment stages. Taxonomic profiles will be evaluated before and after antimicrobial photodynamic therapy (aPDT) and compared among the standard needle irrigation (SNI), passive ultrasonic irrigation (PUI), and laser-activated irrigation (LAI) grou |
Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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Changes in Microbial Functional Gene Profiles
Ramy czasowe: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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Changes in microbial functional gene profiles will be evaluated using shotgun metagenomic sequencing of root canal samples collected at S1, S2, and S3. Functional gene profiles will be compared across sampling stages and among the SNI, PUI, and LAI groups |
Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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Changes in Antimicrobial Resistance Gene Profiles
Ramy czasowe: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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Antimicrobial resistance genes (ARGs) in root canal microbial samples will be characterized using shotgun metagenomic sequencing. Changes in ARG profiles will be evaluated across S1, S2, and S3 and compared among the SNI, PUI, and LAI groups. |
Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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Changes in Intracanal Inflammatory Cytokine Levels
Ramy czasowe: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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Intracanal levels of IL-1β, IL-6, IL-8, IL-10, TNF-α, and IFN-γ will be measured using enzyme-linked immunosorbent assay (ELISA) in samples collected at S1, S2, and S3. Changes in cytokine levels will be evaluated across sampling stages and compared among the four study groups. |
Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Nihan Çelik Uzun, Assistant Professor, Karadeniz Technical University Faculty of Dentistry
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 25-AKD-307
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data (IPD) will not be shared with other researchers to protect participant privacy and confidentiality. Study findings will be reported in aggregate form in scientific publications
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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