Type 2 Diabetes Mellitus (T2DM)NCT06931678
Photodynamic Therapy in Root Canal Treatment of T2DM Patients: Microbiome Analysis Via Next-Gen Sequencing
A study testing aPDT in people with Type 2 Diabetes Mellitus (T2DM) and Necrotic Pulp, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Necrotic Pulp, Apical Periodontitis
- What is being tested?
- aPDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2024to 7 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Show all 11Show fewer
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Faculty of Dentistry, University of Health Sciences
Ankara, Etlik, 06010
About this study
Official title: 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
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.
Read the detailed description
Systemic diseases such as Type 2 Diabetes Mellitus (T2DM) are known to influence both the etiology and healing process of endodontic diseases. T2DM is characterized by chronic hyperglycemia and impaired immune responses, which may negatively affect the resolution of periapical inflammation following root canal treatment. Apical periodontitis (AP) is a common endodontic pathology, often resulting from bacterial infection in the root canal system. The prevalence and severity of AP are higher in diabetic patients, and studies have shown reduced survival rates of endodontically treated teeth in this population.
The primary aim of this study is to evaluate the effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjunctive disinfection method following conventional root canal preparation in T2DM patients with AP. aPDT utilizes a photosensitizer-methylene blue in this study-that, when activated by light of a specific wavelength, generates reactive oxygen species to eliminate residual microorganisms in complex anatomical areas such as isthmuses and lateral canals.
The study will utilize next-generation sequencing (NGS) of the 16S rRNA gene to assess bacterial diversity and quantify microbial elimination before and after aPDT application. The healing response of periapical lesions will also be monitored. The findings aim to contribute to improved treatment strategies and outcomes for endodontic therapy in systemically compromised patients, particularly those with T2DM.
- Being tested
- aPDT
- Medical subject headings
- Diabetes Mellitus, Type 2, Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aPDTProcedure or surgery
This intervention involves the application of antimicrobial photodynamic therapy (aPDT) using methylene blue as a photosensitizer, followed by activation with a light source at an appropriate wavelength. The protocol is applied after conventional root canal preparation and irrigation. The aPDT protocol is standardized and performed in both medically healthy patients and patients with Type 2 Diabetes Mellitus (T2DM), allowing comparison of microbiological and clinical outcomes between the two groups. This intervention aims to enhance root canal disinfection, particularly in anatomically complex areas that are difficult to reach with traditional methods.
| Study group | Role | What they receive |
|---|---|---|
| Necrotic pulped, mature teeth with apical periodontitis | Experimental | This study arm involves the application of antimicrobial photodynamic therapy (aPDT) as an adjunct to conventional root canal treatment in mature permanent teeth diagnosed with apical periodontitis and pulp necrosis. Following standard chemomechanical preparation, methylene blue is used as the photosensitizer, activated by a specific wavelength light source to enhance disinfection of the root canal system. Receives: Procedure: aPDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Radiographic Assessment of Lesion Healing at 6 months
Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.
Measured: Postoperative an avarage of 6 months
Change in Pain Level at day 1, day 3, and day 7 Post-Treatment
Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at day 1, day 3, and day 7 post-procedure.
Measured: Post-Treatment at day 1, day 3, and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start21 Oct 2024
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor
- Investigators
- Hulde Korucu, DDS, Principal investigator, University of Health Sciences Gülhane Faculty of Dentistry Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931678
- Sponsor's protocol ID
- HKORUCU2
- Other IDs
- 37379
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The impact of gender differences on pain assessment in the study was also evaluated. Additionally, the effect of age on lesion healing was analyzed. Since the study examines the effects of demographic data on lesion healing and post-treatment pain, demographic data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06931678
- Acronym / sponsor ID
- HKORUCU2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 17 Apr 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.
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.
Detailed description
Systemic diseases such as Type 2 Diabetes Mellitus (T2DM) are known to influence both the etiology and healing process of endodontic diseases. T2DM is characterized by chronic hyperglycemia and impaired immune responses, which may negatively affect the resolution of periapical inflammation following root canal treatment. Apical periodontitis (AP) is a common endodontic pathology, often resulting from bacterial infection in the root canal system. The prevalence and severity of AP are higher in diabetic patients, and studies have shown reduced survival rates of endodontically treated teeth in this population.
The primary aim of this study is to evaluate the effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjunctive disinfection method following conventional root canal preparation in T2DM patients with AP. aPDT utilizes a photosensitizer-methylene blue in this study-that, when activated by light of a specific wavelength, generates reactive oxygen species to eliminate residual microorganisms in complex anatomical areas such as isthmuses and lateral canals.
The study will utilize next-generation sequencing (NGS) of the 16S rRNA gene to assess bacterial diversity and quantify microbial elimination before and after aPDT application. The healing response of periapical lesions will also be monitored. The findings aim to contribute to improved treatment strategies and outcomes for endodontic therapy in systemically compromised patients, particularly those with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Necrotic pulped, mature teeth with apical periodontitis | Experimental | Procedure: aPDTThis study arm involves the application of antimicrobial photodynamic therapy (aPDT) as an adjunct to conventional root canal treatment in mature permanent teeth diagnosed with apical periodontitis and pulp necrosis. Following standard chemomechanical preparation, methylene blue is used as the photosensitizer, activated by a specific wavelength light source to enhance disinfection of the root canal system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Individuals aged between 18 and 65 years
Key exclusion criteria (7 listed)
- • Severe periodontal disease
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 |
|---|---|---|
| aPDTThis intervention involves the application of antimicrobial photodynamic therapy (aPDT) using methylene blue as a photosensitizer, followed by activation with a light source at an appropriate wavelength. The protocol is applied after conventional root canal preparation and irrigation. The aPDT protocol is standardized and performed in both medically healthy patients and patients with Type 2 Diabetes Mellitus (T2DM), allowing comparison of microbiological and clinical outcomes between the two groups. This intervention aims to enhance root canal disinfection, particularly in anatomically complex areas that are difficult to reach with traditional methods. | Procedure or surgery | Necrotic pulped, mature teeth with apical periodontitis |
Primary outcome
1. Radiographic Assessment of Lesion Healing at 6 months
Time frame: Postoperative an avarage of 6 months
Lesion healing will be evaluated using periapical radiographs with the parallel technique, and the Periapical Index (PAI) will be used for the assessment of lesion healing.
Change in Pain Level at day 1, day 3, and day 7 Post-Treatment
Time frame: Post-Treatment at day 1, day 3, and day 7
Pain levels will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 100 (worst pain), measured at day 1, day 3, and day 7 post-procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Yes. The impact of gender differences on pain assessment in the study was also evaluated. Additionally, the effect of age on lesion healing was analyzed. Since the study examines the effects of demographic data on lesion healing and post-treatment pain, demographic data will be shared.
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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. This study is not recruiting at the moment.
Hulde Korucu, DDS principal investigator
University of Health Sciences Gülhane Faculty of Dentistry Department of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aPDT in people with Type 2 Diabetes Mellitus (T2DM) and Necrotic Pulp, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 11 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: finished, as of the sponsor's last update on 17 Apr 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1. Radiographic Assessment of Lesion Healing at 6 months (time frame: Postoperative an avarage of 6 months). The study lists 2 primary outcomes in all. 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 Apr 2025.