An interventional study of Calcium Hydroxide (CH) and Diclofenac Sodium (DCS) in Post Endodontic Pain, sponsored by Mustafa Kemal University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Mustafa Kemal University · Not applicable, Interventional, and Treatment
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.
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.
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Working length was determined using a size 15 K-file and an apex locator (Morita Root ZX, Tokyo, Japan) and confirmed radiographically. Chemomechanical preparation was performed as described in the protocol. After drying with paper points, 1 mL of distilled water mixed with 1 g calcium hydroxide powder was placed as the intracanal medicament.
Drug: Calcium Hydroxide (CH)
Procedures as in Arm 1. After drying with paper points, 1 mL of distilled water mixed with 1 g diclofenac sodium powder was placed as the intracanal medicament.
Drug: Diclofenac Sodium (DCS)
Procedures as in Arm 1. After drying with paper points, 1 mL of distilled water mixed with 950 mg calcium hydroxide powder and 50 mg diclofenac sodium powder was placed as the intracanal medicament.
Drug: Calcium Hydroxide + Diclofenac Sodium (CH + DCS)
1 mL distilled water mixed with 1 g calcium hydroxide powder, placed into the root canals using a lentulo spiral.
1 mL distilled water mixed with 1 g diclofenac sodium powder, placed into the root canals using a lentulo spiral.
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.
Post-Endodontic Pain
Pre-operative (before treatment) and post-operative pain were assessed using the Visual Analog Scale (VAS), a 100 mm horizontal line with numerical values. Patients rated their pain on the VAS, and pain severity was categorized as follows: No pain (0 mm), mild pain (1-19 mm), moderate pain (20-49 mm), severe pain (50-79 mm), and very severe pain (80-100 mm). Post-operative pain measurements were taken on Days 1, 2, 3, 4, 5, 6, and 7 after intracanal medicament application.
Time frame: Baseline and Days 1-7 post-treatment
Plan to share: No — Individual participant data will not be shared to protect patient privacy and confidentiality.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Mustafa Kemal University