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Comparison of Calcium Hydroxide and Diclofenac Sodium as Intracanal Medicaments on Periapical Healing: A Fractal Analysis Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Turkey
Merve Sarı
RECRUITING
Hatay
Contact Information
Primary
Merve Sarı, DDS,MSc
sarimerve94@outlook.com
+905546430401
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 60
Treatments
Experimental: Diclofenac sodium
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. The medicament is to be condensed to the canal orifice with a sterile paper point.
Active_comparator: Calcium hydroxide
1 g of CH (Kalsin, Konya, Turkey) 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. The medicament is to be condensed to the canal orifice with a sterile paper point.
Related Therapeutic Areas
Sponsors
Leads: Mustafa Kemal University

This content was sourced from clinicaltrials.gov