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NCT Number: NCT07633405

Photodynamic Therapy as an Adjunct in Periodontal Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental School, Catholic University of Santiago de Guayaquil (UCSG)

Guayaquil, Guayas, 090101, Ecuador

Location contact

GABRIELA G ZAMBRANO MANZABA, DDS

CONTACT

[email protected]

9546298543

GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS

PRINCIPAL_INVESTIGATOR

GABRIELA ZAMBRANO MANZABA, DDS

CONTACT

[email protected]

9546298543

HECTOR A LEMA GUTIERREZ, DDS

SUB_INVESTIGATOR

PABLO M REYES CUENCA, DDS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and Root Planing

Procedure

Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.

antimicrobial photodynamic therapy

Procedure

Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.

Primary outcomes

  1. Change in Probing Pocket Depth (PPD)

    Time frame: 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.

Secondary outcomes

  1. Change in Clinical Attachment Level (CAL)

    Time frame: 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.

  2. Change in Bleeding on Probing (BOP)

    Time frame: Baseline and 30 Days

    Percentage of sites presenting bleeding on probing after periodontal examination.

  3. Change in Plaque Index (PI)

    Time frame: Baseline and 30 Days

    Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index.

  4. Change in Gingival Index (GI)

    Time frame: Baseline and 30 Days

    Mean gingival index score assessed according to the Löe and Silness criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

GABRIELA G ZAMBRANO MANZABA, DDS

CONTACT

[email protected]

+19546298543

Sponsors and collaborators

Lead sponsor

Universidad Catolica Santiago de Guayaquil

Other

Registry information

Official study title

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

Acronym: PDT-PERIO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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