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

NCT07389772 | Enrolling By Invitation

• 1 other identifier: 2025.10.03
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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), Interleukin-6 (IL-6) and Tumour Necrosis Factor alpha (TNF-α), and Interleukin-10 (IL-10) levels.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Immediately after the procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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)

You may not qualify if:

• 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%,
• \. 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.

Sponsors & Collaborators

• bengisu yüksel: lead

Study Sites (1)

Kirikkale University Faculty of Dentistry

Kırıkkale, Kırıkkale, 71450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• dilek hancerliogulları, associate professor

  Kırıkkale University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: phd student

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)