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Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study

NCT07609888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-27

No results posted yet for this study

Summary

Gum disease (periodontitis) affects millions of people worldwide and can lead to tooth loss if untreated. The standard treatment is a deep cleaning procedure called non-surgical periodontal therapy (NSPT), where a dentist removes bacterial buildup from beneath the gums. Sometimes, harmful bacteria remain after this cleaning and the disease can return.

This study tests whether adding a light-based antibacterial treatment - called photodynamic therapy (PDT) - to the standard deep cleaning improves results. PDT works by placing a harmless green dye (indocyanine green) into the gum pocket, then shining a specific laser light on it. The light activates the dye and kills the remaining bacteria without antibiotics.

Who can join: Adults aged 18 and over diagnosed with moderate gum disease (Stage II periodontitis) with gum pocket depths of 4-5 mm.

How it works: Each participant receives both treatments - standard cleaning on one side of the mouth, and standard cleaning plus PDT on the other side. This allows a fair comparison within the same person.

What is measured: Gum pocket depth, gum attachment level, and gum bleeding - checked at the start of the study and again after 3 months.

The study was conducted at Thumbay University Hospital, UAE

Conditions

  • Periodontitis
  • Chronic Periodontitis (Disorder)

Interventions

PROCEDURE

Non-Surgical Periodontal Therapy (NSPT)

Full-mouth mechanical debridement using ultrasonic scaling and area-specific Gracey curettes to remove supra- and subgingival calculus and plaque biofilm. Applied to all sites in both arms.

DEVICE

Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser

Indocyanine green (ICG) photosensitizing dye (25 mg lyophilized powder reconstituted to 5 mg/ml with sterile water) was delivered into the periodontal pocket via a 27-gauge needle. The dye was then activated using an Elexxion AG 810 nm diode laser. The laser fiber tip was positioned at the base of the pocket and moved in an apico-coronal direction parallel to the root surface. Applied to test sites only, immediately following NSPT.

Sponsors & Collaborators

  • Gulf Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-06-01
Completion
2024-06-15

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07609888 on ClinicalTrials.gov