NCT07070453

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 8, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

January 24, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

periodontitis; antimicrobial photodinamic therapy

Outcome Measures

Primary Outcomes (1)

  • Microbiology outcome

    Changes in the microbiome collected from periodontal pockets sequencing 16S ribosomal RNA gene

    From enrollment to the end of treatment at 3 months.

Secondary Outcomes (1)

  • Clinical outcome

    From enrollment to the end of treatment at 3 months.

Study Arms (2)

Non-surgical periodontal treatment

ACTIVE COMPARATOR

Conventional non-surgical treatment - scaling and root planing

Procedure: Non-surgical periodontal treatment

Antimicrobial photodynamic therapy

EXPERIMENTAL

Scaling and root planing + aPDT (antimicrobial photodynamic therapy)

Procedure: Scaling and root planing + aPDT

Interventions

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.

Non-surgical periodontal treatment

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.

Antimicrobial photodynamic therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older with periodontitis diagnosed according to EFP/APA 2018 criteria and with at least 10 teeth in the mouth.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Egas Moniz School of Health and Science

Almada, Monte Da Caparica, 2825-084, Portugal

RECRUITING

Egas Moniz School of Health and Science

Almada, Monte Da Caparica, 2829-511, Portugal

ACTIVE NOT RECRUITING

Related Links

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Ricardo Dr. Alves, phd

    Egas Moniz School of Science and Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2025

First Posted

July 17, 2025

Study Start

April 8, 2025

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations