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

NCT07609888 | Completed

• 2 other identifiers: Mds2022-012021MDSPerio01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

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

Outcome Measures

Primary Outcomes (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.

  Baseline and 3 months

Secondary Outcomes (3)

• Change in Bleeding on Probing (BOP)

  Baseline and 3 months

• Change in Gingival Recession

  Baseline and 3 months

• Change in Clinical Attachment Level (CAL)

  Baseline and 3 months

Study Arms (2)

NSPT Alone (Control)

ACTIVE COMPARATOR

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)

NSPT + Antimicrobial Photodynamic Therapy (Test)

EXPERIMENTAL

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.

Procedure: Non-Surgical Periodontal Therapy (NSPT); Device: Antimicrobial Photodynamic Therapy (aPDT) with Indocyanine Green and 810 nm Diode Laser

Interventions

Non-Surgical Periodontal Therapy (NSPT) PROCEDURE

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.

NSPT + Antimicrobial Photodynamic Therapy (Test); NSPT Alone (Control)

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

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.

Also known as: aPDT, Photodynamic Therapy, ICG-PDT

NSPT + Antimicrobial Photodynamic Therapy (Test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Thumbay University Hospital, Postgraduate Research Centre

Ajman, United Arab Emirates

Location

Related Publications (4)

• 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.

  PMID: 30133749 RESULT

• 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.

  PMID: 31859395 RESULT

• 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.

  PMID: 32383274 RESULT

• 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.

  PMID: 29926495 RESULT

Related Links

• IRB - Gulf Medical University

MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis

Interventions

Lasers, Semiconductor; Photochemotherapy

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: he outcomes assessor was masked to treatment allocation during clinical parameter recording. Standardized acrylic stents and a UNC-15 mm periodontal probe were used to ensure consistent and unbiased measurements at baseline and three months.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 15, 2024
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

AE (1)