Photodynamic Therapy as an Adjunct in Periodontal Treatment (PDT-PERIO)
2 juni 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: GABRIELA G ZAMBRANO MANZABA, DDS
- Telefonnummer: +19546298543
- E-post: gabriela.zambrano06@cu.ucsg.edu.ec
Studieorter
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Guayas
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Guayaquil, Guayas, Ecuador, 090101
- Dental School, Catholic University of Santiago de Guayaquil (UCSG)
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Underutredare:
- HECTOR A LEMA GUTIERREZ, DDS
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Kontakt:
- GABRIELA G ZAMBRANO MANZABA, DDS
- Telefonnummer: 9546298543
- E-post: gabriela.manzaba30@gmail.com
-
Kontakt:
- GABRIELA ZAMBRANO MANZABA, DDS
- Telefonnummer: 9546298543
- E-post: gabriela.zambrano06@cu.ucsg.edu.ec
-
Underutredare:
- PABLO M REYES CUENCA, DDS
-
Huvudutredare:
- GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Scaling and Root Planing (SRP)
Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone.
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Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
|
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Experimentell: 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.
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Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Probing Pocket Depth (PPD)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Clinical Attachment Level (CAL)
Tidsram: 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)
Tidsram: Baseline and 30 Days
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Percentage of sites presenting bleeding on probing after periodontal examination.
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Baseline and 30 Days
|
|
Change in Plaque Index (PI)
Tidsram: 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)
Tidsram: Baseline and 30 Days
|
Mean gingival index score assessed according to the Löe and Silness criteria.
|
Baseline and 30 Days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Wang P, Sun F, Ling X. Effectiveness of photodynamic therapy as an adjunctive treatment for periodontitis: A systematic review and meta-analysis. J Stomatol Oral Maxillofac Surg. 2025 Mar;126(2):102036. doi: 10.1016/j.jormas.2024.102036. Epub 2024 Sep 5.
- Nie M, Huang P, Peng P, Shen D, Zhao L, Jiang D, Shen Y, Wei L, Bible PW, Yang J, Wang J, Wu Y. Efficacy of photodynamic therapy as an adjunct to scaling and root planing on clinical parameters and microbial composition in subgingival plaque of periodontitis patients: A split-mouth randomized clinical trial. J Periodontol. 2024 Jun;95(6):535-549. doi: 10.1002/JPER.23-0195. Epub 2024 Mar 19.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
28 juli 2026
Primärt slutförande (Beräknad)
30 augusti 2026
Avslutad studie (Beräknad)
27 september 2026
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CEISH-UCSG-045-2025. - CEISH-
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
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.
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