Retreatment and Diabetes

NCT07679880 | Completed

• 1 other identifier: 2025/336
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apical Periodontitis

Keywords

endodontics; diabetes mellitus; retreatment

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (2)

• Analgesic consumption after nonsurgical endodontic retreatment

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

• Association between HbA1c level and postoperative pain intensity

  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.

Study Arms (2)

Patient with Diabetes mellitus

EXPERIMENTAL

Procedure: root canal retreatment

Healty patient

EXPERIMENTAL

Procedure: root canal retreatment

Interventions

root canal retreatment PROCEDURE

root canal retreatment

Healty patient; Patient with Diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: July 1, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)