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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Nihan Çelik Uzun, Assistant Professor
- Numero di telefono: +90 4623774813 +90 5557256407
- Email: nihancelik@ktu.edu.tr
Luoghi di studio
-
-
Ortahisar
-
Trabzon, Ortahisar, Turchia (Türkiye)
- Reclutamento
- Karadeniz Technical University Faculty of Dentistry
-
Contatto:
- Nihan Çelik Uzun, Assistant Professor
- Numero di telefono: +90 5557256407
- Email: nihancelik@ktu.edu.tr
-
Investigatore principale:
- Nihan ÇELİK UZUN, Assistant Professor
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)
Lasso di tempo: Up to 7 days after treatment (24 hours, 72 hours, and day 7)
|
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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Periapical Radiographic Healing Assessed Using the Periapical Index (PAI)
Lasso di tempo: From baseline through 12 months after treatment (baseline, immediately post-treatment, month 6, and month 12)
|
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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in Root Canal Microbial Composition
Lasso di tempo: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
|
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)
|
|
Changes in Microbial Functional Gene Profiles
Lasso di tempo: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
|
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)
|
|
Changes in Antimicrobial Resistance Gene Profiles
Lasso di tempo: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
|
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)
|
|
Changes in Intracanal Inflammatory Cytokine Levels
Lasso di tempo: Day 1 (before treatment, after irrigation activation, and after antimicrobial photodynamic therapy)
|
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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nihan Çelik Uzun, Assistant Professor, Karadeniz Technical University Faculty of Dentistry
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 25-AKD-307
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .