Photodynamic Therapy in Root Canal Treatment of T2DM Patients: Microbiome Analysis Via Next-Gen S… (NCT06931678) | Clinical Trial Compass
CompletedNot Applicable
Photodynamic Therapy in Root Canal Treatment of T2DM Patients: Microbiome Analysis Via Next-Gen Sequencing
Turkey (Türkiye)20 participantsStarted 2024-10-21
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • 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
Exclusion Criteria:
* • 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Radiographic Assessment of Lesion Healing at 6 months
Timeframe: Postoperative an avarage of 6 months
2
Change in Pain Level at day 1, day 3, and day 7 Post-Treatment
Timeframe: Post-Treatment at day 1, day 3, and day 7