PeriodontitisPerioFPSNCT07070453
Effect of Photodynamic Therapy as an Adjunct to Non-Surgical Treatment of Periodontitis
A study testing Non-surgical periodontal treatment and Scaling and root planing + aPDT in people with Periodontitis, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 2 sites in Portugal.
Trial summary
Photodynamic therapy (PDT) is an innovative technique that utilizes light-activated agents, known as photosensitizers, to produce reactive oxygen species capable of targeting and eliminating pathogens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non-surgical periodontal treatment and Scaling and root planing + aPDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesPortugal
- Study dates
- 8 Apr 2025to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older with periodontitis diagnosed according to EFP/APA 2018 criteria and with at least 10 teeth in the mouth.
Who cannot join
- Periodontal treatment in the previous six months; use of antibiotics, NSAIDs or immunosuppressants in the previous six months; acute oral infection; pregnant or breastfeeding women; teeth with grade III mobility; pockets with PD > 10 mm; use of antimicrobial mouthwash in the previous two months; patients with diabetes mellitus.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites, 1 recruiting
- Recruiting
Egas Moniz School of Health and Science
Almada, Monte Da Caparica, 2825-084
Filipa Sousa, Masters, +351 915028912, filipampsousa@gmail.com
- Active, not recruiting
Egas Moniz School of Health and Science
Almada, Monte Da Caparica, 2829-511
About this study
Photodynamic therapy (PDT) is an innovative technique that utilizes light-activated agents, known as photosensitizers, to produce reactive oxygen species capable of targeting and eliminating pathogens. This therapeutic approach has been explored in a variety of medical fields due to its versatility and minimal invasiveness. In the context of periodontal diseases, PDT has emerged as a promising adjunctive treatment in the non-surgical management of periodontitis. Periodontitis, a chronic inflammatory disease caused by the accumulation of pathogenic bacteria in the subgingival environment, is often treated with mechanical debridement, including scaling and root planing (SRP). However, these conventional methods may not always achieve complete bacterial eradication. PDT, when used in conjunction with SRP, has the potential to significantly enhance bacterial elimination. The use of photosensitizers, activated by specific wavelengths of light, leads to the generation of singlet oxygen, which can effectively kill a broad spectrum of periodontal pathogens, including those resistant to antibiotics. As an adjunctive therapy, PDT can improve the clinical outcomes of non-surgical periodontitis treatment by reducing bacterial load, promoting tissue healing, and potentially decreasing the need for more invasive procedures. The ability of PDT to target bacteria without harming surrounding tissues makes it an attractive option for patients who require a non-invasive treatment approach. In conclusion, photodynamic therapy is a valuable addition to periodontal treatment regimens, offering enhanced bacterial reduction and improved therapeutic outcomes in the management of periodontitis.
- Conditions
- Periodontitis
- Being tested
- Non-surgical periodontal treatment, Scaling and root planing + aPDT
- Keywords
- periodontitis; antimicrobial photodinamic therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Removal of deposits above and below the gum line using hand or ultrasonic tools and thorough smoothing of root surfaces to discourage re-accumulation of bacteria.
Scaling and root planing + aPDTProcedure or surgery
Non-invasive treatment that uses a combination of a light-sensitive compound (photosensitizer), specific light, and oxygen to generate reactive oxygen species (ROS) that kill bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical periodontal treatment | Active comparator | Conventional non-surgical treatment - scaling and root planing Receives: Procedure: Non-surgical periodontal treatment |
| Antimicrobial photodynamic therapy | Experimental | Scaling and root planing + aPDT (antimicrobial photodynamic therapy) Receives: Procedure: Scaling and root planing + aPDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiology outcome
Changes in the microbiome collected from periodontal pockets sequencing 16S ribosomal RNA gene
Measured: From enrollment to the end of treatment at 3 months.
Secondary outcomes (1)
Clinical outcome
Probing depth, measuring in millimeters the distance from the gingival margin to the base of a sulcus or periodontal pocket, using a periodontal probe.
Measured: From enrollment to the end of treatment at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start8 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Dr. Alves, phd, Principal investigator, Egas Moniz School of Science and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070453
- Sponsor's protocol ID
- aPDT FPS
- Other IDs
- CiiEM Investiga
- Acronym
- PerioFPS
- Status last verified
- Jul 2025
- First submitted
- 24 Jan 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photodynamic Therapy as an Adjunct to Non-Surgical Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT07070453
- Acronym / sponsor ID
- PerioFPS / aPDT FPS
- Conditions
- Periodontitis
- Keywords
- periodontitis; antimicrobial photodinamic therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 17 Jul 2025 (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.
Photodynamic therapy (PDT) is an innovative technique that utilizes light-activated agents, known as photosensitizers, to produce reactive oxygen species capable of targeting and eliminating pathogens. This therapeutic approach has been explored in a variety of medical fields due to its versatility and minimal invasiveness. In the context of periodontal diseases, PDT has emerged as a promising adjunctive treatment in the non-surgical management of periodontitis. Periodontitis, a chronic inflammatory disease caused by the accumulation of pathogenic bacteria in the subgingival environment, is often treated with mechanical debridement, including scaling and root planing (SRP). However, these conventional methods may not always achieve complete bacterial eradication. PDT, when used in conjunction with SRP, has the potential to significantly enhance bacterial elimination. The use of photosensitizers, activated by specific wavelengths of light, leads to the generation of singlet oxygen, which can effectively kill a broad spectrum of periodontal pathogens, including those resistant to antibiotics. As an adjunctive therapy, PDT can improve the clinical outcomes of non-surgical periodontitis treatment by reducing bacterial load, promoting tissue healing, and potentially decreasing the need for more invasive procedures. The ability of PDT to target bacteria without harming surrounding tissues makes it an attractive option for patients who require a non-invasive treatment approach. In conclusion, photodynamic therapy is a valuable addition to periodontal treatment regimens, offering enhanced bacterial reduction and improved therapeutic outcomes in the management of periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical periodontal treatment | Active comparator | Procedure: Non-surgical periodontal treatmentConventional non-surgical treatment - scaling and root planing |
| Antimicrobial photodynamic therapy | Experimental | Procedure: Scaling and root planing + aPDTScaling and root planing + aPDT (antimicrobial photodynamic therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or older with periodontitis diagnosed according to EFP/APA 2018 criteria and with at least 10 teeth in the mouth.
Key exclusion criteria (1 listed)
- Periodontal treatment in the previous six months; use of antibiotics, NSAIDs or immunosuppressants in the previous six months; acute oral infection; pregnant or breastfeeding women; teeth with grade III mobility; pockets with PD > 10 mm; use of antimicrobial mouthwash in the previous two months; patients with diabetes mellitus.
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 |
|---|---|---|
| Non-surgical periodontal treatmentRemoval of deposits above and below the gum line using hand or ultrasonic tools and thorough smoothing of root surfaces to discourage re-accumulation of bacteria. | Procedure or surgery | Non-surgical periodontal treatment |
| Scaling and root planing + aPDTNon-invasive treatment that uses a combination of a light-sensitive compound (photosensitizer), specific light, and oxygen to generate reactive oxygen species (ROS) that kill bacteria. | Procedure or surgery | Antimicrobial photodynamic therapy |
Primary outcome
Microbiology outcome
Time frame: From enrollment to the end of treatment at 3 months.
Changes in the microbiome collected from periodontal pockets sequencing 16S ribosomal RNA gene
1 secondary outcome
Clinical outcome
Time frame: From enrollment to the end of treatment at 3 months.
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 17 Jul 2025.
- LED siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ricardo Dr. Alves, phd principal investigator
Egas Moniz School of Science and Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment and Scaling and root planing + aPDT in people with Periodontitis, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 2 sites in Portugal.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Contact Filipa Sousa, Master (00351 915028912, filipampsousa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiology outcome (time frame: From enrollment to the end of treatment at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.