Photodynamic Therapy as an Adjunct in Periodontal Treatment

Official title

Clinical Evaluation of Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Treatment of Periodontal Disease: A Split-Mouth Randomized Controlled Clinical Trial

Overview

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.

Detailed description

Periodontitis is a chronic inflammatory disease characterized by the destruction of the supporting tissues of the teeth and is one of the leading causes of tooth loss worldwide. Scaling and root planing (SRP) is considered the gold standard non-surgical treatment; however, complete elimination of periodontal pathogens may be difficult in deep periodontal pockets and anatomically complex sites.

Antimicrobial photodynamic therapy (aPDT) has emerged as a minimally invasive adjunctive treatment. This technique combines a photosensitizing agent, toluidine blue O, with low-level laser irradiation to produce reactive oxygen species capable of destroying periodontal pathogens while minimizing damage to host tissues.

This study will be conducted at the Dental Clinic of the Universidad Católica de Santiago de Guayaquil, Ecuador. Thirty adult patients diagnosed with periodontitis will be enrolled. A split-mouth randomized design will be used, with one hemiarch receiving SRP alone (control) and the contralateral hemiarch receiving SRP plus aPDT (test group).

Clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI) will be recorded at baseline and at 30-day follow-up. The primary objective is to compare the clinical effectiveness of adjunctive aPDT versus conventional SRP alone in improving periodontal health outcomes.

The study has been approved by the Ethics Committee for Research in Human Subjects of the Universidad Católica de Santiago de Guayaquil (CEISH-UCSG) and will be conducted in accordance with ethical principles for human research.

Interventions

• Procedure Scaling and Root Planing
  Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
• Procedure Antimicrobial Photodynamic Therapy
  Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.

Primary outcome measures

• Change in Probing Pocket Depth (PPD) [Time frame: Baseline and 30 Days]

Secondary outcome measures (4)

• Change in Clinical Attachment Level (CAL) [Time frame: Baseline and 30 Days]
• Change in Bleeding on Probing (BOP) [Time frame: Baseline and 30 Days]
• Change in Plaque Index (PI) [Time frame: Baseline and 30 Days]
• Change in Gingival Index (GI) [Time frame: Baseline and 30 Days]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Ecuador · 1 center

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

Publications

• 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
• 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

Identifiers

NCT: NCT07633405 · CEISH-UCSG-045-2025. - CEISH-

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗