Comparison of Inter-appointment Pain Reduction During Root Canal Treatment in Symptomatic Apical Periodontitis by Using Intracanal Medicaments; Chlorhexidine Gel and Single Antibiotic Paste Nitrofurantoin

NCT07198919 | Enrolling By Invitation Phase 1

• 1 other identifier: AIDM/ERC/03/2025/01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to find out which of two medications-Chlorhexidine Gel or Nitrofurantoin-works better in reducing pain between root canal treatment visits. Sometimes, patients with infected teeth (called symptomatic apical periodontitis) continue to feel pain between treatment appointments. To help with this, dentists use medications inside the cleaned tooth canal. In this trial, 220 patients will be divided into two groups. One group will receive Chlorhexidine Gel, and the other will receive Nitrofurantoin paste inside their tooth during the first treatment visit. Pain levels will be recorded before treatment, and again after 24 and 48 hours using a pain scale from 0 (no pain) to 10 (severe pain). No pain medicine will be given unless the patient feels very uncomfortable. The study is taking place at the Altamash Institute of Dental Medicine in Karachi, and will help dentists understand which medication helps patients feel better faster during root canal treatment.

Conditions

Intracanal Medicament

Keywords

intracanal medicament

Outcome Measures

Primary Outcomes (1)

• Percentage Reduction in Inter-Appointment Pain Score

  Change in patient-reported pain intensity, measured using the Visual Analogue Scale (VAS), from pre-treatment to 24 and 48 hours post-treatment. Pain reduction will be calculated using the formula: \[(Pre-treatment VAS score - Post-treatment VAS score) / Pre-treatment VAS score\] × 100

  Pain scores will be assessed before treatment, then at 24 hours and 48 hours after the first treatment visit.

Study Arms (2)

Chlorhexidine

ACTIVE COMPARATOR

Drug: Chlorhexidine gel

Nitrofurantoin

ACTIVE COMPARATOR

Drug: Nitrofurantoin 100 MG

Interventions

Chlorhexidine gel DRUG

0.12% Chlorhexidine gel (Consepsis Ultradent)

Also known as: Consepsis Ultradent

Chlorhexidine

Nitrofurantoin 100 MG DRUG

Nitrofurantoin Tablets 100mg

Nitrofurantoin

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with single rooted permanent teeth of both arches.
• Patients with a pulpal status of necrosis with or without periapical radiolucency, confirmed using Electric Pulp Test (EPT) and Cold Test.
• Male and female patients age of 16 to 45 yrs.
• Patients of both genders.

You may not qualify if:

• Patients with uncontrolled diabetes.
• Presence of periapical granuloma or cyst confirmed via radiographic evaluation.
• Patient is on any medication that affects pain, inflammation and infection like analgesic, antibiotics since last 7 days
• Patient requiring endodontic re-treatment.
• Patients with immature teeth with open apices.
• Patients with calcified canals.

Sponsors & Collaborators

• Altamash Institute of Dental Medicine: lead

Study Sites (1)

AIDM

Karachi, Sindh, 74500, Pakistan

Location

MeSH Terms

Interventions

Nitrofurantoin

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS II Resident Trainee

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: September 30, 2025
• Study Start: May 20, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-05

Locations

PA (1)