Effect of DCS on Post-Endodontic Pain

NCT06632015 | Completed

• 1 other identifier: HMKU-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Endodontic Pain

Keywords

Endodontics; Post-Endodontic Pain; Calcium Hydroxide; Diclofenac Sodium; Intracanal Medicament; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Days 1-7 post-treatment

Study Arms (3)

Calcium Hydroxide (CH)

EXPERIMENTAL

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)

Diclofenac Sodium (DCS)

EXPERIMENTAL

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)

Calcium Hydroxide + Diclofenac Sodium (CH+DCS)

EXPERIMENTAL

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)

Interventions

Calcium Hydroxide (CH) DRUG

1 mL distilled water mixed with 1 g calcium hydroxide powder, placed into the root canals using a lentulo spiral.

Calcium Hydroxide (CH)

Diclofenac Sodium (DCS) DRUG

1 mL distilled water mixed with 1 g diclofenac sodium powder, placed into the root canals using a lentulo spiral.

Diclofenac Sodium (DCS)

Calcium Hydroxide + Diclofenac Sodium (CH + DCS) DRUG

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.

Calcium Hydroxide + Diclofenac Sodium (CH+DCS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years
• Systemically healthy (ASA I-II)
• Diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis in mandibular molars (characterized by spontaneous pain or prolonged pain in response to cold test, and presence of percussion sensitivity)
• Positive response to Electric Pulp Testing (EPT) and cold testing
• Periapical Index (PAI) score of 1 or 2 according to Ørstavik et al. (1986)
• Pre-operative pain level ≥50 mm on the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 100 (most severe pain)

You may not qualify if:

• History of psychiatric disorders
• Allergic reactions
• Pregnancy
• Use of analgesics within the previous 24 hours
• Use of antibiotics within the last 3 months
• Teeth with a sinus tract or history of abscess formation
• Periodontal pocket depth \>3 mm
• Root resorption, root fractures, or ankylosis
• Previous root canal treatment on the selected tooth
• Teeth requiring prosthetic restoration

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Antakya, Turkey (Türkiye)

Location

Related Publications (1)

• Fidanoglu B, Tufenkci P, Sari M. The effects of calcium hydroxide and diclofenac sodium as root canal medicaments on post-endodontic pain: a double-blinded, parallel group, randomized controlled clinical trial. Odontology. 2025 Nov 9. doi: 10.1007/s10266-025-01252-9. Online ahead of print.

  PMID: 41206809 DERIVED

MeSH Terms

Interventions

Calcium Hydroxide; Diclofenac; Cycloserine

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 8, 2024
• Study Start: January 22, 2024
• Primary Completion: May 17, 2024
• Study Completion: May 24, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)