Comparing two medicines placed inside the root canal to help periapical lesions heal
Comparison of Calcium Hydroxide and Diclofenac Sodium as Intracanal Medicaments on Periapical Healing: A Fractal Analysis Study
This study will test whether placing calcium hydroxide or diclofenac sodium inside the root canal helps periapical lesions heal in adults having retreatment of single-rooted lower teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Mustafa Kemal University Academic / other |
| Locations | 1 site (Hatay, Antakya) |
| Trial ID | NCT07237620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–60 who are systemically healthy (ASA I–II) with single-rooted, root-filled mandibular teeth showing post-treatment apical periodontitis (PAI ≥3) and who need endodontic retreatment are ideal candidates.
Not a fit: Patients with multi-rooted teeth, significant systemic illness (ASA III+), pregnancy, or those unable to attend a 12-month follow-up are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the result could identify a more effective intracanal medicament to speed or improve bone healing after retreatment.
How similar studies have performed: Calcium hydroxide is a well-established intracanal medicament with supporting evidence for healing, while diclofenac sodium used inside root canals is less common and supported mainly by limited or preliminary studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hatay, Antakya
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.