NCT06931678Completed
Photodynamic Therapy in Root Canal Treatment of T2DM Patients: Microbiome Analysis Via Next-Gen Sequencing
Evaluation of the Effectiveness of Root Canal Treatment Performed Using Photodynamic Therapy in Teeth With Apical Periodontitis in Patients With Type 2 Diabetes Through Next-Generation Sequencing Microbiome Analysis
Source: ClinicalTrials.gov · Last updated 17 Apr 2025
Brief summary (registry, in English)
This clinical study investigates the effectiveness of antimicrobial photodynamic therapy (aPDT) as an additional disinfection method in root canal treatment of patients with Type 2 Diabetes Mellitus (T2DM) who have apical periodontitis (AP). T2DM is known to negatively impact the healing of periapical tissues due to impaired immune response. In this study, methylene blue is used as a photosensitizer, activated by a specific wavelength of light to eliminate residual bacteria that are difficult to reach with conventional cleaning methods. The bacterial load and changes in the root canal microbiome will be analyzed using next-generation sequencing (NGS) of the 16S rRNA gene. The goal is to assess the microbial elimination and healing of periapical lesions, and to improve treatment outcomes in diabetic patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 8 Apr 2025
- Start date
- 21 Oct 2024
- Primary completion date
- 7 Apr 2025
- Lead sponsor
- Saglik Bilimleri Universitesi
- Diseases
- Type 2 diabetes
- NCT number
- NCT06931678
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 21 Oct 2024 to the primary completion date, 7 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • Severe periodontal disease
- Internal or external root resorption
- Open apex (immature root development)
- Suspected vertical root fracture
- Non-restorable teeth
- Teeth with previous root canal treatment
- Presence of developmental dental anomalies
Who the study is looking for
- • Individuals aged between 18 and 65 years
- Voluntarily agree to participate in the study and attend follow-up sessions
- Systemically healthy individuals (no systemic diseases)
- Not taking antihypertensive or antidiabetic medications
- Not pregnant
- No use of corticosteroids or antibiotics within the last 3 months
- No history of smoking
- No acute pain or extraoral swelling
- No sinus tract or acute apical abscess
- Presence of a periapical lesion with a Periapical Index (PAI) score ≥ 3
- Presence of a mature, single-rooted permanent tooth with completed root development
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gulhane Faculty of Dentistry, University of Health Sciences Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.