PeriodontitisPDT-PERIONCT07633405
Photodynamic Therapy as an Adjunct in Periodontal Treatment
A study testing Scaling and Root Planing and Antimicrobial Photodynamic Therapy in people with Periodontitis and Periodontal Disease, run by Universidad Catolica Santiago de Guayaquil at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis, Periodontal Disease
- What is being tested?
- Scaling and Root Planing and Antimicrobial Photodynamic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEcuador
- Study dates
- 28 Jul 2026to 27 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ecuador1 site
Dental School, Catholic University of Santiago de Guayaquil (UCSG)
Guayaquil, Guayas, 090101
About this study
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
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.
Read the 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.
- Conditions
- Periodontitis, Periodontal Disease
- Being tested
- Scaling and Root Planing, Antimicrobial Photodynamic Therapy
- Keywords
- Periodontitis, Periodontal Disease, Antimicrobial Photodynamic Therapy, Photodynamic Therapy, aPDT, SRP, Clinical attachment level, Low level Laser therapy, Gingival Index
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.
Antimicrobial Photodynamic TherapyProcedure or surgery
Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planing (SRP) | Active comparator | Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone. Receives: Procedure: Scaling and Root Planing |
| 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. Receives: Procedure: Scaling and Root Planing; Procedure: Antimicrobial Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 Days
Secondary outcomes (4)
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.
Measured: Baseline and 30 Days
Change in Bleeding on Probing (BOP)
Percentage of sites presenting bleeding on probing after periodontal examination.
Measured: Baseline and 30 Days
Change in Plaque Index (PI)
Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index.
Measured: 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.
Measured: Baseline and 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start28 Jul 2026
- Primary completion30 Aug 2026
- Study completion27 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Catolica Santiago de Guayaquil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Guadalupe Zambrano Manzaba, Universidad Catolica Santiago de Guayaquil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633405
- Sponsor's protocol ID
- CEISH-UCSG-045-2025. - CEISH-
- Acronym
- PDT-PERIO
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 39244026Nie 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.
PubMed 38501762
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07633405
- Acronym / sponsor ID
- PDT-PERIO / CEISH-UCSG-045-2025. - CEISH-
- Conditions
- Periodontitis, Periodontal Disease
- Keywords
- Periodontitis, Periodontal Disease, Antimicrobial Photodynamic Therapy, Photodynamic Therapy, aPDT, SRP, Clinical attachment level, Low level Laser therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Catolica Santiago de GuayaquilUniversity, hospital or other
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 27 Sep 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planing (SRP) | Active comparator | Procedure: Scaling and Root PlaningHemiarch 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 | Procedure: Scaling and Root Planing, Procedure: Antimicrobial Photodynamic TherapyHemiarch treated with conventional scaling and root planing combined with adjunctive antimicrobial photodynamic therapy using toluidine blue O and low-level laser irradiation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and Root PlaningConventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus. | Procedure or surgery | Scaling and Root Planing (SRP), Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT) |
| Antimicrobial Photodynamic TherapyAdjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing. | Procedure or surgery | Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT) |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 39244026Wang 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.
- Background: PubMed 38501762Nie 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing and Antimicrobial Photodynamic Therapy in people with Periodontitis and Periodontal Disease, run by Universidad Catolica Santiago de Guayaquil at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Probing Pocket Depth (PPD) (time frame: Baseline and 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.