CompletedNot Applicable

Retreatment and Diabetes

Turkey (Türkiye)50 participantsStarted 2026-01-01

Plain-language summary

ABSTRACT This prospective, controlled, single-center clinical study aims to compare postoperative pain levels and analgesic consumption after nonsurgical endodontic retreatment in individuals with diabetes mellitus and systemically healthy individuals. In addition, the study aims to evaluate the relationship between HbA1c levels, type of antidiabetic medication, and postoperative pain within the diabetes mellitus group. A total of 54 patients with single-rooted teeth requiring nonsurgical endodontic retreatment due to persistent endodontic problems following previous root canal treatment will be included. Participants will be allocated into two groups according to systemic status: a diabetes mellitus group and a systemically healthy control group, with 27 patients in each group. All retreatment procedures will be performed by a single operator using a standardized clinical protocol. Previous root canal filling materials will be removed, root canals will be reshaped, irrigated according to a standardized irrigation protocol, and obturated using an epoxy resin-based root canal sealer and gutta-percha cones with the cold lateral condensation technique. Postoperative pain will be assessed using a Visual Analog Scale at 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7. Analgesic consumption will be recorded at the same follow-up time points. Intergroup comparisons, changes in pain scores over time, and associations between HbA1c levels, antidiabetic medication type, and postoperative pain will be evaluated using appropriate statistical tests. The statistical significance level will be set at p \< 0.05.

Who can participate

Age range

18 Years – 60 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: Patients aged 18 to 60 years. Patients classified as medically healthy (ASA I) for the control group or as having diabetes mellitus (ASA II or ASA III) for the diabetes mellitus group. Single-rooted, single-canal teeth with closed apices. Teeth with previous root canal treatment completed at least 4 years before enrollment. Teeth with root canal filling ending 1 to 4 mm coronal to the radiographic apex. Teeth diagnosed with asymptomatic apical periodontitis. Teeth with a periapical index score between 2 and 4. Teeth without pain on percussion or palpation. Teeth not requiring periodontal or prosthetic treatment. Teeth suitable for rubber dam isolation. Exclusion Criteria: Use of analgesics, antibiotics, or corticosteroids within the last 2 weeks before nonsurgical endodontic retreatment. Teeth with periodontal attachment loss. Teeth with vertical root fracture, external root resorption, or perforation. Teeth with fractured prosthetic restorations. Non-restorable teeth. Patients with severe pain and/or acute apical abscess. Pregnant patients. Teeth with calcified root canals. Individuals considered unable to comply with treatment procedures because of intellectual disability, developmental delay, or advanced age.

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

Postoperative pain intensity assessed using the 100-mm Visual Analog Scale (VAS)

Timeframe: 6, 12, 24, and 48 hours after nonsurgical endodontic retreatment and on postoperative days 3, 4, 5, 6, and 7

Trial details

NCT IDNCT07679880

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Apical Periodontitis trials