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Photodynamic Therapy as an Adjunct in Periodontal Treatment (PDT-PERIO)

2. juni 2026 oppdatert av: Gabriela Guadalupe Zambrano Manzaba, Universidad Catolica Santiago de Guayaquil

Clinical Evaluation of Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Treatment of Periodontal Disease: A Split-Mouth Randomized Controlled Clinical Trial

This study aims to evaluate the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjunct to scaling and root planing (SRP) in the treatment of periodontitis. A split-mouth design will be used, in which one hemiarch receives conventional SRP and the contralateral hemiarch receives SRP combined with aPDT. Clinical periodontal parameters, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI), will be assessed at baseline and 30 days after treatment. The study seeks to determine whether adjunctive aPDT improves periodontal outcomes compared with conventional non-surgical periodontal therapy alone.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Periodontitis is a chronic inflammatory disease characterized by the destruction of the supporting tissues of the teeth and is one of the leading causes of tooth loss worldwide. Scaling and root planing (SRP) is considered the gold standard non-surgical treatment; however, complete elimination of periodontal pathogens may be difficult in deep periodontal pockets and anatomically complex sites.

Antimicrobial photodynamic therapy (aPDT) has emerged as a minimally invasive adjunctive treatment. This technique combines a photosensitizing agent, toluidine blue O, with low-level laser irradiation to produce reactive oxygen species capable of destroying periodontal pathogens while minimizing damage to host tissues.

This study will be conducted at the Dental Clinic of the Universidad Católica de Santiago de Guayaquil, Ecuador. Thirty adult patients diagnosed with periodontitis will be enrolled. A split-mouth randomized design will be used, with one hemiarch receiving SRP alone (control) and the contralateral hemiarch receiving SRP plus aPDT (test group).

Clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI) will be recorded at baseline and at 30-day follow-up. The primary objective is to compare the clinical effectiveness of adjunctive aPDT versus conventional SRP alone in improving periodontal health outcomes.

The study has been approved by the Ethics Committee for Research in Human Subjects of the Universidad Católica de Santiago de Guayaquil (CEISH-UCSG) and will be conducted in accordance with ethical principles for human research.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090101
        • Dental School, Catholic University of Santiago de Guayaquil (UCSG)
        • Underetterforsker:
          • HECTOR A LEMA GUTIERREZ, DDS
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • PABLO M REYES CUENCA, DDS
        • Hovedetterforsker:
          • GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 to 65 years.
  • Diagnosis of Stage I, II, III, or IV periodontitis according to the 2018 World Workshop Classification.
  • Presence of at least two hemiarches with periodontal pockets ≥5 mm suitable for a split-mouth design.
  • Systemically healthy individuals.
  • No periodontal treatment received within the previous 6 months.
  • No use of antibiotics, anti-inflammatory drugs, or antiseptic mouth rinses within the previous 3 months.
  • Ability and willingness to provide written informed consent and attend follow-up visits.

Exclusion Criteria:

  • Uncontrolled systemic diseases that may affect healing or immune response.
  • Use of antibiotics, corticosteroids, or immunosuppressive medications within the previous 3 months.
  • Active smokers consuming more than 10 cigarettes per day.
  • Pregnant or breastfeeding women.
  • Presence of dental implants, defective restorations, or teeth with Grade III mobility in the selected study sites.
  • Known allergy to toluidine blue O or any component of the photosensitizer.
  • Individuals unable or unwilling to attend the 30-day follow-up visit.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Scaling and Root Planing (SRP)
Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone.
Fremgangsmåte: Scaling and Root Planing
Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
Eksperimentell: Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT)
Hemiarch treated with conventional scaling and root planing combined with adjunctive antimicrobial photodynamic therapy using toluidine blue O and low-level laser irradiation.
Fremgangsmåte: Scaling and Root Planing
Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
Fremgangsmåte: Antimicrobial Photodynamic Therapy
Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Probing Pocket Depth (PPD)
Tidsramme: Baseline and 30 Days
Mean change in probing pocket depth (PPD), measured in millimeters using a UNC-15 periodontal probe, comparing baseline and 30-day follow-up between treatment groups.
Baseline and 30 Days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Clinical Attachment Level (CAL)
Tidsramme: Baseline and 30 Days
Mean change in clinical attachment level (CAL), measured in millimeters from the cemento-enamel junction to the bottom of the periodontal pocket.
Baseline and 30 Days
Change in Bleeding on Probing (BOP)
Tidsramme: Baseline and 30 Days
Percentage of sites presenting bleeding on probing after periodontal examination.
Baseline and 30 Days
Change in Plaque Index (PI)
Tidsramme: Baseline and 30 Days
Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index.
Baseline and 30 Days
Change in Gingival Index (GI)
Tidsramme: Baseline and 30 Days
Mean gingival index score assessed according to the Löe and Silness criteria.
Baseline and 30 Days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidad Catolica Santiago de Guayaquil

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

28. juli 2026

Primær fullføring (Antatt)

30. august 2026

Studiet fullført (Antatt)

27. september 2026

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CEISH-UCSG-045-2025. - CEISH-

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

A decision regarding the sharing of individual participant data (IPD) has not yet been made. Data sharing plans will be determined after study completion, publication of primary results, and in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable regulations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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