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

NCT07123792 | Completed DMC

• 1 other identifier: Dr Fatimah
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

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

  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)

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

Study Arms (3)

Calcium Hydroxide group

EXPERIMENTAL

Participants in this group will receive 20% calcium hydroxide paste as the intracanal medicament after root canal instrumentation. The medicament will be placed using a Lentulo spiral, excess removed from the chamber, and the tooth sealed with glass ionomer cement. Pain will be assessed at 0, 6, 24, and 48 hours postoperatively.

Drug: Calcium Hydroxide (20%)

Chlorhexidine group

EXPERIMENTAL

Participants in this group will receive 2% chlorhexidine gel as the intracanal medicament following canal preparation. It will be placed with a Lentulo spiral and sealed in the same manner. Postoperative pain will be evaluated at the same intervals.

Drug: Chlorhexidine Gel (2%)

Modified triple antibiotic paste

EXPERIMENTAL

Participants in this group will receive a modified triple antibiotic paste made from ciprofloxacin, metronidazole, and clindamycin in a 1:1:1 ratio by weight. The paste will be placed inside the canal using a Lentulo spiral and sealed as per protocol. Pain will be recorded at 0, 6, 24, and 48 hours post-treatment.

Drug: Modified Triple Antibiotic Paste

Interventions

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.

Also known as: Modified triple antibiotic paste

Calcium Hydroxide group

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.

Also known as: Calcium hyroxide

Chlorhexidine group

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.

Also known as: Chlorhexidine

Modified triple antibiotic paste

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (1)

• Khan AM, Gangoo IKA, Ali NA, Khan M, Javed MQ, AlAttas MH, Abulhamael AM, Bahammam HA, Alsofi L, Yahya RSA. The Effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on Pain in Teeth with Symptomatic Apical Periodontitis: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Feb 10;20(4):3091. doi: 10.3390/ijerph20043091.

  PMID: 36833788 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Calcium Hydroxide; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Beenish Qureshi, BDS, FCPS

  HITEC-Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 14, 2025
• Study Start: June 3, 2024
• Primary Completion: May 3, 2025
• Study Completion: June 3, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)