Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and Root Planing (SRP) | Active Comparator | Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and Root Planing | Procedure | Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 30 Days |
| Change in Bleeding on Probing (BOP) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GABRIELA G ZAMBRANO MANZABA, DDS | Contact | +19546298543 | gabriela.zambrano06@cu.ucsg.edu.ec |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental School, Catholic University of Santiago de Guayaquil (UCSG) | Guayaquil | Guayas | 090101 | Ecuador |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39244026 | Background | 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. | |
| 38501762 | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
Not provided
Not provided
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.
Not provided
Not provided
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.
| 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. |
|
Percentage of sites presenting bleeding on probing after periodontal examination.
| Baseline and 30 Days |
| Change in Plaque Index (PI) | Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index. | Baseline and 30 Days |
| Change in Gingival Index (GI) | Mean gingival index score assessed according to the Löe and Silness criteria. | Baseline and 30 Days |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |