Health Trials

Photodynamic Therapy as an Adjunct in Periodontal Treatment

ConditionsPeriodontitisPeriodontal Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Catolica Santiago de Guayaquil

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scaling and Root Planing

    Procedure/Surgery

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

  • Antimicrobial Photodynamic Therapy

    Procedure/Surgery

    Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Scaling and Root Planing (SRP)Active comparator 1 intervention
Group B: Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT)Experimental treatment 2 interventions

Trial outcomes

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.

Time frame
Baseline and 30 Days

Secondary outcomes

1

Change in Clinical Attachment Level (CAL)

Mean change in clinical attachment level (CAL), measured in millimeters from the cemento-enamel junction to the bottom of the periodontal pocket.

Time frame
Baseline and 30 Days
2

Change in Bleeding on Probing (BOP)

Percentage of sites presenting bleeding on probing after periodontal examination.

Time frame
Baseline and 30 Days
3

Change in Plaque Index (PI)

Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index.

Time frame
Baseline and 30 Days
4

Change in Gingival Index (GI)

Mean gingival index score assessed according to the Löe and Silness criteria.

Time frame
Baseline and 30 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Catolica Santiago de Guayaquil

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: