Type 2 DiabetesTLR9 in T2DMNCT07389772
INVESTIGATION OF THE EFFECT OF DIFFERENT ACTIVATION TECHNIQUES ON TLR9, IL6, IL10, TNF-ALFA LEVELS IN HEALTHY AND TYPE 2 DIABETIC PATIENTS WITH APICAL PERIODONTITIS REQUIRING RETREATMENT
An observational study of Type 2 Diabetes, run by bengisu yüksel at 1 site in Turkey (Türkiye).
Trial summary
The subject of this thesis study is the effects of SWEEPS laser and ultrasonic activation methods on the immune response in the treatment of apical periodontitis in healthy individuals and patients with Type 2 diabetes requiring retreatment, based on a comparative investigation of Toll-like Receptor 9 (TLR-9)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2026to 15 May 2027
- Phase
- Observational
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will include patients aged 18-64 years who present to the Department of Endodontics, Faculty of Dentistry, Kırıkkale University, with an indication for root canal therapy and are diagnosed with either a healthy group(Group 1) or type 2 diabet mellitus (Group 2).
Who may be able to join
- Patients aged 18-50 years
- Patients with ASA I status
- Patients with Type 2 diabetes whose HbA1c values are between 5.5% and 9.0%, with diabetes diagnosis confirmed by medical history and laboratory tests (HbA1c test)
- Upper and lower incisors and lower premolars with chronic apical periodontitis,
- Teeth requiring retreatment with a PAI score ≥3 will be included in the study. (15)
Who cannot join
- ASA II or higher,
- Pregnant women or those suspected of being pregnant,
- Patients with localized or generalized periodontitis,
- Patients with inflammatory or autoimmune diseases such as hepatitis, HIV infection, immunosuppressive chemotherapy, bleeding disorders, Behçet's syndrome, and arthritis,
- Individuals with HbA1c levels above 9%,
- 5. Those who have used antibiotics within the last month and anti-inflammatory drugs within the last week, 6. Smokers, 7. Patients with periodontal pockets greater than 3 mm in the relevant tooth, 8. Those with internal or external root resorption, 9. Those with swelling, palpation pain, or a fistula in the relevant area, 10. Those with root fracture or incomplete root formation, 11. Teeth that cannot be isolated with a rubber dam will not be included in the study.
- The name, surname, age, gender, contact information, and tooth number to be treated of patients included in the study will be recorded on the case report form. Periapical radiographs will be taken of the relevant teeth prior to root canal treatment to examine the root canal anatomy. The periapical health status of each tooth will be assessed using the PAI score.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kirikkale University Faculty of Dentistry
Kirikkale, Kırıkkale, 71450
About this study
The subject of this thesis study is the effects of SWEEPS laser and ultrasonic activation methods on the immune response in the treatment of apical periodontitis in healthy individuals and patients with Type 2 diabetes requiring retreatment, based on a comparative investigation of Toll-like Receptor 9 (TLR-9), Interleukin-6 (IL-6) and Tumour Necrosis Factor alpha (TNF-α), and Interleukin-10 (IL-10) levels.
Read the detailed description
Patients included in the study will be randomly assigned to two main groups using www.randomizer.org.
DOS samples will be collected in both the control and experimental groups during both sessions. A total of 90 patients will be divided into two main groups: systemically healthy individuals (n=45) and patients with type 2 diabetes (n=45). Each main group will be divided into three subgroups (n=15) according to the irrigation protocol applied: conventional irrigation, ultrasonic activation (16) and SWEEPS laser activation (17) will not be applied, and periapical exudate samples will be taken from all patients in both sessions.
GROUP 1- Healthy patients Group 1A - Conventional irrigation Group 1B - Ultrasonic activation
Group 1C - SWEEPS laser activation
GROUP 2 - Patients with type 2 diabetes Group 2A - Conventional irrigation Group 2B - Ultrasonic activation Group 2C - SWEEPS laser activation
After collecting DOS samples from the relevant teeth, patients will be administered local anaesthesia with 1.8 ml articaine HCl (Ultracain DS Forte; Pharma Vision San. Ve Tic. A.Ş. Istanbul, Turkey) containing 1:100,000 epinephrine, and the teeth will be isolated using a rubber dam. After disinfecting the crowns of the relevant teeth with 2.5% NaOCl, the caries and existing restorations will be removed, and the access cavity will be disinfected with 2.5% NaOCl. After determining the root canal orifices, Protaper Universal Retreatment (Dentsply Mallefer, Ballagues, Switzerland) will be used for root canal filling removal. (18) Subsequently, the working length will be determined using an electronic apex locator (Ai-Pex, Woodpecker Medical Instrument Co., Guilin, China) and confirmed with a periapical radiograph. For the canal shaping procedure, Eighteeth (Changzhou Sifary Medical Technology Co., Ltd., China) endodontic motor and Protaper Gold (Dentsply Sirona, Charlotte, NC, USA) nickel-titanium rotary files, using the crown-down technique, up to #F5.
After each file change, the root canal will be irrigated with 2 mL of 2.5% NaOCl. After the root canal enlargement procedure is completed, the following solutions will be applied for final irrigation: 10 mL of 2.5% NaOCl, 10 mL of 0.5% sodium thiosulphate, 5 mL of distilled water, 5 mL of 17% EDTA, and 5 mL of serum.
After the sample collection process is completed, ELISA analysis will be performed using commercial kits to measure TNF-α, IL-6, IL-10, and TLR-9 levels.
The analysis of the samples will be carried out at the Laboratory of the Scientific and Technological Research Application and Research Centre at Kırıkkale University.
ELISA analysis methods will be performed according to the manufacturer's application instructions.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healty group | Patients included in the study will be randomly assigned to two main groups using www.randomizer.org. DOS samples will be collected in both the control and experimental groups during both sessions. A total of 90 patients will be divided into two main groups: systemically healthy individuals (n=45) and patients with type 2 diabetes (n=45). Each main group will be divided into three subgroups (n=15) according to the irrigation protocol applied: conventional irrigation, ultrasonic activation , and SWEEPS laser activation . Periapical exudate samples will be collected from all patients in both sessions. | |
| type 2 diabet mellitus group | Patients included in the study will be randomly assigned to two main groups using www.randomizer.org. DOS samples will be collected in both the control and experimental groups during both sessions. A total of 90 patients will be divided into two main groups: systemically healthy individuals (n=45) and patients with type 2 diabetes (n=45). Each main group will be divided into three subgroups (n=15) according to the irrigation protocol applied: conventional irrigation, ultrasonic activation , and SWEEPS laser activation . Periapical exudate samples will be collected from all patients in both sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLR9 expression levels in periapical exudate and gingival crevicular fluid samples
TLR9 will be measured in periapical exudate and gingival crevicular fluid (GCF) samples obtained during routine root canal treatment. The analysis will be performed using the ELISA method. The aim is to compare expression levels between healthy individuals and patients with type 2 diabetes mellitus.
Measured: Immediately after the procedure
Secondary outcomes (1)
Correlation analysis between TLR9, IL6, IL10, and TNF-α levels in periapical exudate and gingival crevicular fluid samples
This study will evaluate the correlation of TLR9, IL6, IL10, and TNF-α within and between two groups, namely healthy individuals and patients diagnosed with type 2 diabetes mellitus, under different irrigation protocols. Using appropriate statistical methods to examine the intra-group and inter-group relationships between biomarkers in pulp tissue, dentin fluid, and gingival crevicular fluid samples, correlation analyses will be performed separately for each group and comparatively between groups.
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start28 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bengisu yüksel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, bengisu yüksel, Kırıkkale University
- Investigators
- dilek hancerliogulları, associate professor, Study director, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389772
- Sponsor's protocol ID
- 2025.10.03
- Acronym
- TLR9 in T2DM
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 10 Feb 2026
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF THE EFFECT OF DIFFERENT ACTIVATION TECHNIQUES ON TLR9, IL6, IL10, TNF-ALFA LEVELS IN HEALTHY AND TYPE 2 DIABETIC PATIENTS WITH APICAL PERIODONTITIS REQUIRING RETREATMENT
- ClinicalTrials.gov ID
- NCT07389772
- Acronym / sponsor ID
- TLR9 in T2DM / 2025.10.03
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- bengisu yükselUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 5 Feb 2026 (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.
The subject of this thesis study is the effects of SWEEPS laser and ultrasonic activation methods on the immune response in the treatment of apical periodontitis in healthy individuals and patients with Type 2 diabetes requiring retreatment, based on a comparative investigation of Toll-like Receptor 9 (TLR-9), Interleukin-6 (IL-6) and Tumour Necrosis Factor alpha (TNF-α), and Interleukin-10 (IL-10) levels.
Detailed description
Patients included in the study will be randomly assigned to two main groups using www.randomizer.org.
DOS samples will be collected in both the control and experimental groups during both sessions. A total of 90 patients will be divided into two main groups: systemically healthy individuals (n=45) and patients with type 2 diabetes (n=45). Each main group will be divided into three subgroups (n=15) according to the irrigation protocol applied: conventional irrigation, ultrasonic activation (16) and SWEEPS laser activation (17) will not be applied, and periapical exudate samples will be taken from all patients in both sessions.
GROUP 1- Healthy patients Group 1A - Conventional irrigation Group 1B - Ultrasonic activation
Group 1C - SWEEPS laser activation
GROUP 2 - Patients with type 2 diabetes Group 2A - Conventional irrigation Group 2B - Ultrasonic activation Group 2C - SWEEPS laser activation
After collecting DOS samples from the relevant teeth, patients will be administered local anaesthesia with 1.8 ml articaine HCl (Ultracain DS Forte; Pharma Vision San. Ve Tic. A.Ş. Istanbul, Turkey) containing 1:100,000 epinephrine, and the teeth will be isolated using a rubber dam. After disinfecting the crowns of the relevant teeth with 2.5% NaOCl, the caries and existing restorations will be removed, and the access cavity will be disinfected with 2.5% NaOCl. After determining the root canal orifices, Protaper Universal Retreatment (Dentsply Mallefer, Ballagues, Switzerland) will be used for root canal filling removal. (18) Subsequently, the working length will be determined using an electronic apex locator (Ai-Pex, Woodpecker Medical Instrument Co., Guilin, China) and confirmed with a periapical radiograph. For the canal shaping procedure, Eighteeth (Changzhou Sifary Medical Technology Co., Ltd., China) endodontic motor and Protaper Gold (Dentsply Sirona, Charlotte, NC, USA) nickel-titanium rotary files, using the crown-down technique, up to #F5.
After each file change, the root canal will be irrigated with 2 mL of 2.5% NaOCl. After the root canal enlargement procedure is completed, the following solutions will be applied for final irrigation: 10 mL of 2.5% NaOCl, 10 mL of 0.5% sodium thiosulphate, 5 mL of distilled water, 5 mL of 17% EDTA, and 5 mL of serum.
After the sample collection process is completed, ELISA analysis will be performed using commercial kits to measure TNF-α, IL-6, IL-10, and TLR-9 levels.
The analysis of the samples will be carried out at the Laboratory of the Scientific and Technological Research Application and Research Centre at Kırıkkale University.
ELISA analysis methods will be performed according to the manufacturer's application instructions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healty group | – | –Patients included in the study will be randomly assigned to two main groups using www.randomizer.org. DOS samples will be collected in both the control and experimental groups during both sessions. A total of 90 patients will be divided into two main groups: systemically healthy individuals (n=45) and patients with type 2 diabetes (n=45). Each main group will be divided into three subgroups (n=15) according to the irrigation protocol applied: conventional irrigation, ultrasonic activation , and SWEEPS laser activation . Periapical exudate samples will be collected from all patients in both sessions. |
| type 2 diabet mellitus group | – | –Patients included in the study will be randomly assigned to two main groups using www.randomizer.org. DOS samples will be collected in both the control and experimental groups during both sessions. A total of 90 patients will be divided into two main groups: systemically healthy individuals (n=45) and patients with type 2 diabetes (n=45). Each main group will be divided into three subgroups (n=15) according to the irrigation protocol applied: conventional irrigation, ultrasonic activation , and SWEEPS laser activation . Periapical exudate samples will be collected from all patients in both sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include patients aged 18-64 years who present to the Department of Endodontics, Faculty of Dentistry, Kırıkkale University, with an indication for root canal therapy and are diagnosed with either a healthy group(Group 1) or type 2 diabet mellitus (Group 2).
Key inclusion criteria (5 listed)
Key exclusion criteria (7 listed)
- ASA II or higher,
- Pregnant women or those suspected of being pregnant,
- Patients with localized or generalized periodontitis,
- Patients with inflammatory or autoimmune diseases such as hepatitis, HIV infection, immunosuppressive chemotherapy, bleeding disorders, Behçet's syndrome, and arthritis,
- Individuals with HbA1c levels above 9%,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TLR9 expression levels in periapical exudate and gingival crevicular fluid samples
Time frame: Immediately after the procedure
TLR9 will be measured in periapical exudate and gingival crevicular fluid (GCF) samples obtained during routine root canal treatment. The analysis will be performed using the ELISA method. The aim is to compare expression levels between healthy individuals and patients with type 2 diabetes mellitus.
1 secondary outcome
Correlation analysis between TLR9, IL6, IL10, and TNF-α levels in periapical exudate and gingival crevicular fluid samples
Time frame: Immediately after the procedure
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 10 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
dilek hancerliogulları, associate professor study director
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by bengisu yüksel 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 5 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: enrolling by invitation, as of the sponsor's last update on 10 Feb 2026. 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?
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?
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?
TLR9 expression levels in periapical exudate and gingival crevicular fluid samples (time frame: Immediately after the procedure). 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 10 Feb 2026.