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NCT Number: NCT07123792

Effect of Intracanal Medicaments on Post-Operative Pain in Symptomatic Apical Periodontitis: An RCT

Comparison of different intracanal medicaments during root canal treatment to assess their effect on post-operative pain in teeth with Symptomatic Apical Periodontitis

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

About this study

Pain is the most common clinical symptom associated with endodontic treatment. Symptomatic apical periodontitis (SAP) results in significant post-operative discomfort due to microbial invasion and inflammatory changes in periapical tissues. Intracanal medicaments are used to reduce microbial load and inflammation between treatment appointments, potentially reducing post-treatment pain. This study investigates the comparative effectiveness of three commonly used intracanal medicaments in reducing pain following biomechanical preparation:

Group 1: Calcium hydroxide (CH)

Group 2: Chlorhexidine gel (CHX 2%)

Group 3: Modified Triple Antibiotic Paste (TAP) - a combination of ciprofloxacin, clindamycin, and metronidazole in 1:1:1 ratio

A total of 480 participants with single-rooted teeth diagnosed with symptomatic apical periodontitis will be randomly assigned into three groups (160 in each group). Endodontic treatment will be performed by a single operator under standard protocols. No systemic analgesics or antibiotics will be prescribed. Pain assessment will be done using the Wong-Baker FACES Pain Rating Scale (0-10), and recorded at baseline (0 h), 6 h, 24 h, and 48 h after treatment.

The study aims to provide evidence on the most effective intracanal medicament to minimize post-operative pain, improving patient outcomes and guiding clinical decision-making.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single rooted teeth (Anterior or posterior)
  • Teeth with acute symptomatic apical periodontitis

Exclusion criteria

  • Non-restorable teeth, presence of endo-perio lesions, teeth with acute or chronic apical abcess, teeth with internal/external root resorption
  • Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
  • Patients with parafunctional habits
  • Patients who were allergic to medications that were used in the study
  • Patients who were taking medicines that could influence pain perception
  • Patients that had any serious medical illness or with systemic disorders

Treatment and study plan

Calcium Hydroxide (20%)

Drug

A 20% calcium hydroxide paste will be placed as an intracanal medicament following root canal instrumentation. Applied using a Lentulo spiral, excess is removed, and the tooth is sealed with a glass ionomer temporary restoration.

Other names: Modified triple antibiotic paste

Chlorhexidine Gel (2%)

Drug

A 2% chlorhexidine gel will be used as an intracanal medicament following canal preparation. It will be delivered with a Lentulo spiral, cleaned from the chamber, and the tooth sealed.

Other names: Calcium hyroxide

Modified Triple Antibiotic Paste

Drug

A modified triple antibiotic paste consisting of ciprofloxacin, metronidazole, and clindamycin (1:1:1 by weight) will be placed in the canal using a Lentulo spiral. The excess paste will be removed, and the cavity will be sealed with temporary restorative material.

Other names: Chlorhexidine

Primary outcomes

  1. Post-operative Pain Intensity Measured Using the Wong-Baker FACES Pain Rating Scale (WFPRS)

    Time frame: At baseline (0 hours), 6 hours, 24 hours, and 48 hours post-operatively

    Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale (WFPRS), a validated 6-point facial expression scale. The scale ranges from 0 (no pain) to 10 (worst pain), with corresponding facial images used to help patients subjectively rate their pain. This tool will be used during follow-up calls to determine the patient's level of pain after root canal instrumentation and medicament placement.

    Units of Measurement:

    Score range: 0-10 (intervals of 2)

Sponsors and collaborators

Lead sponsor

HITEC-Institute of Medical Sciences

Other

Registry information

Official study title

Comparison of Different Intracanal Medicaments on Post-operative Pain in Teeth With Symptomatic Apical Periodontitis: A Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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