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NCT Number: NCT07679880

Retreatment and Diabetes

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.

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Key information

Conditions

Apical Periodontitis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Jaw Diseases Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

root canal retreatment

Procedure

root canal retreatment

Primary outcomes

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

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

    Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 mm, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater postoperative pain intensity. Pain will be recorded at each scheduled follow-up assessment.

Secondary outcomes

  1. Analgesic consumption after nonsurgical endodontic retreatment

    Time frame: 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7.

    Analgesic consumption will be recorded at 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7. Participants will record each dose of 400 mg ibuprofen taken for postoperative pain. Higher values indicate greater analgesic consumption.

  2. Association between HbA1c level and postoperative pain intensity

    Time frame: HbA1c level assessed at baseline; postoperative pain assessed at 6, 12, 24, and 48 hours and on postoperative days 3, 4, 5, 6, and 7.

    The association between glycated hemoglobin (HbA1c) levels and postoperative pain intensity measured using the 100-mm Visual Analog Scale (VAS) will be evaluated in participants with diabetes mellitus.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effect of Nonsurgical Endodontic Retreatment on Postoperative Pain in Patients With Diabetes Mellitus: A Prospective Clinical Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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