An interventional study of Scaling and Root Planing and Antimicrobial Photodynamic Therapy in Periodontitis and Periodontal Disease, sponsored by Universidad Catolica Santiago de Guayaquil. Enrolling by invitation at 1 site in Ecuador. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Universidad Catolica Santiago de Guayaquil · Not applicable, Interventional, and Treatment
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.
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 30 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Universidad Catolica Santiago de Guayaquil is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone.
Procedure: Scaling and Root Planing
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
Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.
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
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
Change in Bleeding on Probing (BOP)
Percentage of sites presenting bleeding on probing after periodontal examination.
Time frame: Baseline and 30 Days
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
Change in Gingival Index (GI)
Mean Gingival Index score assessed according to the Löe and Silness criteria. The Gingival Index is scored on a scale from 0 to 3, where 0 indicates normal gingiva, 1 indicates mild inflammation, 2 indicates moderate inflammation, and 3 indicates severe inflammation. Higher scores indicate greater gingival inflammation and a worse clinical outcome.
Time frame: Baseline and 30 Days
Plan to share: Undecided — A decision regarding the sharing of individual participant data (IPD) has not yet been made. Data sharing plans will be determined after study completion, publication of primary results, and in accordance with institutional policies, ethical approvals, participant confidentiality requirements, and applicable regulations.
Ran from Jul 2026 to primary completion in Aug 2026, 1 month.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 1 month is below that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Universidad Catolica Santiago de Guayaquil