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

May 20, 2026 updated by: Gulf Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed Description Periodontitis is a multifactorial inflammatory disease driven by a dysbiotic subgingival microbiome. Despite non-surgical periodontal therapy (NSPT) being the gold standard, complete bacterial elimination is not always achieved, and residual periodontal pathogens such as Porphyromonas gingivalis and Treponema denticola can persist post-treatment. This has led to the exploration of adjunctive therapies to enhance clinical outcomes.

Antimicrobial photodynamic therapy (aPDT) is a non-antibiotic adjunct that uses a photosensitizing dye activated by laser light of a specific wavelength. Upon activation in the presence of oxygen, the dye generates cytotoxic reactive oxygen species and singlet oxygen, which disrupt bacterial cell membranes and DNA. Indocyanine green (ICG), a near-infrared photosensitizer with peak absorption in the 800-830 nm range, demonstrates high uptake among key periodontal pathogens and carries no risk of inducing antimicrobial resistance.

Study Rationale:

Current systematic reviews on aPDT as an adjunct to NSPT report contradictory findings, often attributed to heterogeneous study designs, mixed periodontitis staging, and short follow-up periods. This study addresses these limitations by focusing exclusively on a well-defined patient population with Stage II periodontitis and employing a split-mouth design to minimize inter-subject variability.

Intervention Protocol:

Control sites (NSPT alone):

Supragingival and subgingival debridement was performed using an ultrasonic scaler, followed by subgingival root instrumentation using Gracey curettes (11/12). A customized acrylic stent with a UNC-15 mm periodontal probe was used to standardize probing measurements.

Test sites (NSPT + aPDT):

Following NSPT, indocyanine green dye was reconstituted at a concentration of 5 mg/ml and delivered into the periodontal pocket via a 27-gauge needle, placed to the base of the pocket and withdrawn coronally while injecting. The photosensitizer was then activated using an Elexxion AG 810 nm diode laser, with the fiber tip moved in an apico-coronal direction parallel to the root surface within the pocket.

Randomization:

Sites were randomly allocated to test or control groups using a split-mouth design, ensuring contralateral teeth were assigned to different treatment groups.

Follow-up:

All clinical parameters - probing pocket depth (PD), clinical attachment level (CAL), gingival recession, and bleeding on probing (BOP) - were recorded at baseline and at three months post-treatment by a calibrated examiner using standardized acrylic stents.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
      • Ajman, United Arab Emirates
        • Thumbay University Hospital, Postgraduate Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - Adults aged 18 years and older
  • Diagnosis of Stage II periodontitis according to the 2018 classification of the World Workshop of Periodontology (AAP/EFP)
  • At least two non-adjacent sites with interproximal probing pocket depth of 4-5 mm
  • Interproximal clinical attachment loss of 3-4 mm at affected sites
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Periodontal therapy including scaling and root debridement within the last 12 months
  • Antibiotic use or regular use of mouthwash in the 3 months prior to enrollment
  • Pregnancy
  • Any systemic condition that may affect periodontal healing (e.g. uncontrolled diabetes, immunocompromised states)
  • Regular use of hormonal contraceptives
  • Smoking more than 10 cigarettes per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NSPT Alone (Control)
Control sites received full-mouth non-surgical periodontal therapy (NSPT) consisting of supragingival and subgingival debridement using an ultrasonic scaler and Gracey curettes (Hu-Friedy, Chicago, IL). Oral hygiene instructions were reinforced at each visit. Pocket depth was standardized using an individualized acrylic resin occlusal stent with a UNC-15 periodontal probe.
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.
Other Names:
  • aPDT, Photodynamic Therapy, ICG-PDT
Experimental: NSPT + Antimicrobial Photodynamic Therapy (Test)
Test sites received full-mouth NSPT followed by adjunctive antimicrobial photodynamic therapy (aPDT). Indocyanine green (ICG) dye was reconstituted at 5 mg/ml and delivered to the base of the periodontal pocket via a 27-gauge needle using a coronal withdrawal technique. The photosensitizer was activated using an Elexxion AG 810 nm diode laser, with the fiber tip moved in an apico-coronal direction parallel to the root surface within the pocket.
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.
Other Names:
  • aPDT, Photodynamic Therapy, ICG-PDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Pocket Depth (PD)
Time Frame: Baseline and 3 months
Probing pocket depth measured in millimeters using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent. Measurements recorded at the mesio-buccal surface of the assigned tooth in both control and test sites.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bleeding on Probing (BOP)
Time Frame: Baseline and 3 months
Bleeding on probing recorded as a percentage of sites exhibiting bleeding following gentle probing of the periodontal pocket. Presence or absence of bleeding noted within 30 seconds of probing at each designated site.
Baseline and 3 months
Change in Gingival Recession
Time Frame: Baseline and 3 months
Gingival recession measured in millimeters as the distance from the cemento-enamel junction to the free gingival margin using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
Baseline and 3 months
Change in Clinical Attachment Level (CAL)
Time Frame: Baseline and 3 months
Clinical attachment level measured in millimeters as the distance from the cemento-enamel junction to the base of the periodontal pocket, using a UNC-15 mm periodontal probe standardized with an individualized acrylic resin occlusal stent.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulf Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mds2022-01
  • 2021MDSPerio01 (Other Identifier: Gulf Medical University MDS Thesis 2023-2024)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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