Comparing two medicines placed inside the root canal to help periapical lesions heal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Fifty-four adults with post-treatment apical periodontitis in single-rooted mandibular teeth will be randomly assigned to receive either calcium hydroxide or diclofenac sodium as an intracanal medicament during endodontic retreatment performed by a single experienced clinician. Retreatment uses standardized instrumentation and radiographic confirmation of working length and removal of previous filling material. Periapical healing will be measured radiographically at baseline and after 12 months using fractal analysis to quantify bone regeneration. The primary outcome is the change in fractal dimension between initial and follow-up radiographs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The study is planned to include patients aged 18-60 years who are systemically healthy (ASA I-II), present with apical periodontitis after primary root canal treatment, and have single-rooted, root-filled mandibular teeth with a periapical index (PAI) score of ≥3.

Endodontic treatment failure is to be evaluated based on clinical and radiographic examinations. The duration of the initial endodontic treatment is to be at least four years or longer and/or the teeth are to exhibit clinical symptoms and signs. Previous root canal fillings are to be assessed for obturation quality and classified as satisfactory if they meet the following criteria: no visible voids, good condensation, and termination within 1-2 mm of the radiographic apex. If one or more of these criteria are not fulfilled, the obturation is to be classified as poor quality.

The presence of post-treatment apical periodontitis, poor obturation quality, and/or persistent or newly developed symptoms (such as spontaneous pain, tenderness to palpation or percussion) and/or sinus tract formation are to be considered as indications for retreatment.

Exclusion Criteria:

Patients with a history of psychiatric disorders, allergic reactions, or pregnancy, and those who have taken analgesics within seven days prior to treatment or antibiotics within the previous three months, are to be excluded from the study.

Teeth presenting with a periodontal pocket depth greater than 4 mm, severe coronal destruction preventing rubber dam placement, vertical root fracture, internal or external resorption, ankylosis, overfilling, open apex, or that have undergone surgical or nonsurgical retreatment after primary therapy are to be excluded. Teeth with perforation or fractured instruments are also to be excluded.

Where it's running

• Merve Sarı
  Hatay, Antakya, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Merve Sarı, DDS,MSc — Mustafa Kemal University Hatay, Turkey
• Study coordinator: Merve Sarı, DDS,MSc
• Email: sarimerve94@outlook.com
• Phone: +905546430401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Different endodontic motor motions during root canals and their effect on pain

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• i-PRF regenerative treatment versus conventional non-surgical root canal retreatment for failed front teeth

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.