Periodontal Disease, Periodontitis
Conditions
Keywords
Periodontitis, Periodontal Disease, Antimicrobial Photodynamic Therapy, Photodynamic Therapy, aPDT, SRP, Clinical attachment level, Low level Laser therapy, Gingival Index
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.
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
PROCEDUREScaling and Root Planing
Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
PROCEDUREAntimicrobial 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.
Sponsors
Universidad Catolica Santiago de Guayaquil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Baseline and 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | Baseline and 30 Days | Mean change in clinical attachment level (CAL), measured in millimeters from the cemento-enamel junction to the bottom of the periodontal pocket. |
| Change in Bleeding on Probing (BOP) | Baseline and 30 Days | Percentage of sites presenting bleeding on probing after periodontal examination. |
| Change in Plaque Index (PI) | Baseline and 30 Days | Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index. |
| Change in Gingival Index (GI) | Baseline and 30 Days | Mean gingival index score assessed according to the Löe and Silness criteria. |
Countries
Ecuador
Contacts
CONTACTGABRIELA G ZAMBRANO MANZABA, DDS
Outcome results
None listed