NCT06632015

Effect of DCS on Post-Endodontic Pain

The Effects of Calcium Hydroxide and Diclofenac Sodium on Post-Endodontic Pain: A Double-Blinded, Parallel Group, Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Mustafa Kemal University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized, triple-blind, parallel-group clinical trial was to evaluate the effects of calcium hydroxide (CH), diclofenac sodium (DCS), and their combination (CH+DCS) as intracanal medicaments on post-endodontic pain in mandibular molars diagnosed with symptomatic apical periodontitis. Ninety patients were randomly assigned to three groups (CH, DCS, or CH+DCS; n=30 each). Pain intensity was recorded using a 100 mm Visual Analog Scale (VAS) over 7 days following treatment, and the number of analgesic tablets taken was also recorded. Statistical analyses were performed using Kruskal-Wallis, Friedman, Wilcoxon signed-rank, and Chi-square tests, with significance set at 0.05. The null hypothesis stated that there would be no significant difference in post-endodontic pain among the groups.

Detailed description

This randomized, triple-blind, parallel-group clinical trial included 90 patients aged 18-60 years with a single mandibular molar diagnosed with symptomatic apical periodontitis. Sample size was calculated based on a priori power analysis to detect significant differences in post-endodontic pain, resulting in 30 participants per group. All endodontic procedures were performed by a single clinician under local anesthesia. After tooth isolation and access cavity preparation, working length was determined using K-files and an apex locator, verified radiographically. Chemomechanical preparation was performed using Reciproc files according to canal dimensions. Irrigation was performed using 2.5% NaOCl and 17% EDTA, followed by canal drying. Patients were randomly assigned to three groups according to the intracanal medicament: Group 1 (CH): 1 g Calcium Hydroxide mixed with 1 mL distilled water Group 2 (DCS): 1 g Diclofenac Sodium mixed with 1 mL distilled water Group 3 (CH + DCS): 950 mg Calcium Hydroxide + 50 mg Diclofenac Sodium mixed with 1 mL distilled water The canals were sealed temporarily. Postoperative pain was recorded daily for 7 days using a 100 mm Visual Analog Scale (VAS). Patients also recorded the number of analgesic tablets taken. Pain assessments were conducted by a blinded researcher. For pain management, 400 mg ibuprofen was prescribed if needed, with contact support provided for severe pain. At the second session, medicaments were removed, final irrigation was performed, canals were dried, and obturation was completed using a single-cone technique with gutta-percha and calcium silicate sealer. Teeth were restored with resin composite.

Conditions

• Post Endodontic Pain

Interventions

Type	Name	Description
DRUG	Calcium Hydroxide (CH)	1 mL distilled water mixed with 1 g calcium hydroxide powder, placed into the root canals using a lentulo spiral.
DRUG	Diclofenac Sodium (DCS)	1 mL distilled water mixed with 1 g diclofenac sodium powder, placed into the root canals using a lentulo spiral.
DRUG	Calcium Hydroxide + Diclofenac Sodium (CH + DCS)	1 mL distilled water mixed with 950 mg calcium hydroxide powder and 50 mg diclofenac sodium powder, placed into the root canals using a lentulo spiral.

Timeline

• Start date: 2024-01-22
• Primary completion: 2024-05-17
• Completion: 2024-05-24
• First posted: 2024-10-08
• Last updated: 2025-08-22

Locations

1 site across 1 country: Turkey (Türkiye)