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PeriodontitisaPDT-NSPTNCT07609888

Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis

A study testing Non-Surgical Periodontal Therapy (NSPT) and Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser in people with Periodontitis and Chronic Periodontitis (Disorder), run by Gulf Medical University at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Non-Surgical Periodontal Therapy (NSPT) and Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Arab Emirates
Study dates
1 Jun 2023to 15 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site
  • Thumbay University Hospital, Postgraduate Research Centre

    Ajman

Other trials in United Arab Emirates

About this study

Official title: 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.

Read more

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

Read the 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.

Being tested
Non-Surgical Periodontal Therapy (NSPT), Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser
Keywords
Photodynamic therapy, Antimicrobial photodynamic therapy, Non-surgical periodontal therapy, Periodontal debridement, Indocyanine green, Diode laser, Split-mouth clinical trial, Pocket depth reduction, Clinical attachment level, Bleeding on probing, Subgingival debridement, Periodontal pathogens
Medical subject headings
Periodontitis, Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Surgical Periodontal Therapy (NSPT)Procedure or surgery

    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.

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

    Also called aPDT, Photodynamic Therapy, ICG-PDT

    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.

Study groups in NCT07609888
Study groupRoleWhat they receive
NSPT Alone (Control)Active comparatorControl 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.
Receives: Procedure: Non-Surgical Periodontal Therapy (NSPT)
NSPT + Antimicrobial Photodynamic Therapy (Test)ExperimentalTest 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.
Receives: Procedure: Non-Surgical Periodontal Therapy (NSPT); Device: Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Probing Pocket Depth (PD)

    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.

    Measured: Baseline and 3 months

Secondary outcomes (3)
  1. Change in Bleeding on Probing (BOP)

    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.

    Measured: Baseline and 3 months

  2. Change in Gingival Recession

    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.

    Measured: Baseline and 3 months

  3. Change in Clinical Attachment Level (CAL)

    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.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start1 Jun 2023
  3. Primary completion1 Jun 2024
  4. Study completion15 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Split-mouth design in which each participant contributed two sites - one control site receiving NSPT alone and one test site receiving NSPT with adjunct antimicrobial photodynamic therapy. Each participant served as their own control, with random allocation of sites to treatment arms.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609888
Sponsor's protocol ID
Mds2022-01
Other IDs
2021MDSPerio01
Acronym
aPDT-NSPT
Status last verified
Jun 2026
First submitted
20 May 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):783-803. doi: 10.1902/jop.2017.170172.

    PubMed 30133749
  • Salvi GE, Stahli A, Schmidt JC, Ramseier CA, Sculean A, Walter C. Adjunctive laser or antimicrobial photodynamic therapy to non-surgical mechanical instrumentation in patients with untreated periodontitis: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:176-198. doi: 10.1111/jcpe.13236.

    PubMed 31859395
  • Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

    PubMed 32383274
  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Clin Periodontol. 2018 Jun;45 Suppl 20:S149-S161. doi: 10.1111/jcpe.12945.

    PubMed 29926495

Questions about this trial

What is this clinical trial studying?

A study testing Non-Surgical Periodontal Therapy (NSPT) and Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser in people with Periodontitis and Chronic Periodontitis (Disorder), run by Gulf Medical University at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Probing Pocket Depth (PD) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07609888, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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