NCT06821763

To Measure Post Operative Pain Severity by Using Two Different Intra Canal Medicaments Calcium Hydroxide and Triple Antibiotic Paste in Teeth with Single Roots and Periapical Disease Called Apical Periodontitis

Effect of Calcium Hydroxide on Post Operative Pain Severity in Single Rooted Teeth with Symptomatic Apical Periodontitis

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Komal Ashraf Khan · Academic / Other
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

* The aim of this study is to compare post operative pain effectiveness between two most commonly available intra canal medicaments that are Triple Antibiotic Paste and Calcium Hydroxide during root canal treatment of single rooted teeth with symptomatic apical periodontitis. * Patients visiting OPD will be selected after fulfilment of inclusion criteria and randomly divided into two groups i.e group A patients receiving calcium hydroxide and group B with patients receiving Triple Antibiotic Paste as intra canal medicaments * Patient will be called at 48hrs 72hrs and 96hrs postoperatively. * Effectiveness of intra canal medicaments will be measured as no mild moderate severe on visual analogue scale(VAS).

Detailed description

* This randomized control study is done to compare post operative pain effectiveness of two medicaments that are triple antibiotic paste (TAP)(ciprofloxacin, metronidazole and minocycline in ratio 1:1:1) and calcium hydroxide(CH) during root canal treatment of single rooted teeth with symptomatic apical periodontitis. * Calcium hydroxide being strong base exerts antimicrobial efficiency in reducing and eliminating microorganisms in entire root canal system * TAP is efficient against calcium hydroxide resistant bacteria called as enterococcus faecalis and provides antimicrobial efficiency to inner depths of root canal up to 400 microns. * This study will add further to literature regarding better intracanal medicament among two most widely used. * Sample size includes total 180 participants having two groups each containing 90. * Inclusion criteria have patients with age group 12-45, single rooted teeth, having symptomatic apical periodontitis, patients fulfilling international associates definition of pain * Exclusion criteria includes patients having allergies, unable to take medications, medical conditions like diabetes etc, pregnant patients, teeth with tooth abnormalities like dilacerations open apices etc * Patients will be selected from OPD after fulfilment of inclusion criteria randomly divided into two groups using lottery method * Group A receiving calcium hydroxide group B receiving triple antibiotic paste * Patients will be called post operatively after 48hrs 72hrs and 96hrs * Post operative pain effectiveness will be measured as no mild moderate and severe on visual analogue scale (VAS) * The data will be analyzed in statistical software SPSS v 25. Chi square test will be applied to compare effectiveness in both groups keeping p value less than 0.05 as significant.

Conditions

• Apical Periodontitis
• Irreversible Pulpitis with Apical Periodontitis

Interventions

Type	Name	Description
DRUG	Calcium Hydroxide Intracanal medication	non setting calcium hydroxide(CH) mixed with normal saline and placed as intra canal medicament during first visit of root canal treatment. effectiveness measured after 48hrs, 72hrs and 96hrs
DRUG	triple antibiotic paste (TAP)	mix metronidazole, ciprofloxacin and minocycline in ratio 1:1:1 with normal saline and placed as intra canal medicament during first visit of root canal treatment.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: Pakistan