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Clinical Trials in Turkey / NCT07237620
Recruiting Not applicable

The Effect of Different Intracanal Medicaments on Periapical Lesion Healing

NCT07237620 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-09-15
Last updated
2026-06-08

Condition(s) studied

Periapical Lesion HealingApical Periodontitis

Investigational drug(s) / intervention(s)

Diclofenac sodium

Diclofenac sodium: Group 1: 1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water. Group 2: 1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water. After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length.

Study summary

This study is planned to evaluate the effects of two different intracanal medicaments-calcium hydroxide and diclofenac sodium-on periapical healing following endodontic retreatment. Fifty-four patients will be included and randomly assigned into two groups according to the type of medicament used. All procedures will be performed by a single experienced endodontist under standardized clinical conditions. Periapical lesion healing will be assessed radiographically at baseline and after 12 months using fractal analysis to quantitatively evaluate bone regeneration. The primary outcome will be the change in the fractal dimension values between the initial and follow-up radiographs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Merve Sarı Hatay Antakya Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07237620 on ClinicalTrials.gov ↗ ← All trials in Turkey