Photodynamic Therapy as an Adjunct in Periodontal Treatment

NCT07633405 | Not Yet Recruiting

• 1 other identifier: CEISH-UCSG-045-2025. - CEISH-
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Periodontal Disease

Keywords

Periodontitis; Periodontal Disease; Antimicrobial Photodynamic Therapy; Photodynamic Therapy; aPDT; SRP; Clinical attachment level; Low level Laser therapy; Gingival Index

Outcome Measures

Primary Outcomes (1)

• Change in Probing Pocket Depth (PPD)

  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.

  Baseline and 30 Days

Secondary Outcomes (4)

• Change in Clinical Attachment Level (CAL)

  Baseline and 30 Days

• Change in Bleeding on Probing (BOP)

  Baseline and 30 Days

• Change in Plaque Index (PI)

  Baseline and 30 Days

• Change in Gingival Index (GI)

  Baseline and 30 Days

Study Arms (2)

Scaling and Root Planing (SRP)

ACTIVE COMPARATOR

Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone.

Procedure: Scaling and Root Planing

Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT)

EXPERIMENTAL

Hemiarch treated with conventional scaling and root planing combined with adjunctive antimicrobial photodynamic therapy using toluidine blue O and low-level laser irradiation.

Procedure: Scaling and Root Planing; Procedure: Antimicrobial Photodynamic Therapy

Interventions

Scaling and Root Planing PROCEDURE

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

Scaling and Root Planing (SRP); Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT)

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.

Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Catolica Santiago de Guayaquil: lead

Study Sites (1)

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

Guayaquil, Guayas, 090101, Ecuador

Location

Related Publications (2)

• Wang P, Sun F, Ling X. Effectiveness of photodynamic therapy as an adjunctive treatment for periodontitis: A systematic review and meta-analysis. J Stomatol Oral Maxillofac Surg. 2025 Mar;126(2):102036. doi: 10.1016/j.jormas.2024.102036. Epub 2024 Sep 5.

  PMID: 39244026 BACKGROUND

• Nie M, Huang P, Peng P, Shen D, Zhao L, Jiang D, Shen Y, Wei L, Bible PW, Yang J, Wang J, Wu Y. Efficacy of photodynamic therapy as an adjunct to scaling and root planing on clinical parameters and microbial composition in subgingival plaque of periodontitis patients: A split-mouth randomized clinical trial. J Periodontol. 2024 Jun;95(6):535-549. doi: 10.1002/JPER.23-0195. Epub 2024 Mar 19.

  PMID: 38501762 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Central Study Contacts

GABRIELA G ZAMBRANO MANZABA, DDS

CONTACT

+19546298543; gabriela.zambrano06@cu.ucsg.edu.ec

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed which hemiarch receives adjunctive antimicrobial photodynamic therapy. Clinical measurements and outcome assessments will be performed by an examiner blinded to treatment allocation whenever possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigador

Model Details: This is a randomized split-mouth clinical trial in which each participant receives both interventions. One hemiarch is randomly assigned to scaling and root planing (SRP) alone, while the contralateral hemiarch receives scaling and root planing combined with antimicrobial photodynamic therapy (aPDT). Clinical outcomes are compared between treatment conditions within the same participant.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 28, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

EC (1)