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RECRUITING
NCT07867951
NA

Comparison of Postoperative Pain After Double Antibiotic Paste vs Calcium Hydroxide in Teeth With Symptomatic Apical Periodontitis

Sponsor: College of Physicians and Surgeons Pakistan

View on ClinicalTrials.gov

Summary

This randomized controlled trial aims to compare the mean postoperative pain after using double antibiotic paste (DAP) versus calcium hydroxide (CH) as an intracanal medicament in teeth with symptomatic apical periodontitis. Symptomatic apical periodontitis is a painful dental condition caused by inflammation and destruction of the tissues around the root apex of a tooth. It is diagnosed clinically by a painful response to biting, percussion, or palpation, and radiographically by widening of the periodontal ligament space. Patients aged 16 to 50 years with a single tooth diagnosed with symptomatic apical periodontitis will be randomly divided into two groups. Group A will receive calcium hydroxide as an intracanal medicament, and Group B will receive double antibiotic paste (a mixture of metronidazole and ciprofloxacin). Postoperative pain will be measured using a 10-point Visual Analog Scale (VAS) at 1 hour and 24 hours after treatment. Patients will be contacted by telephone to record their pain scores. The hypothesis is that there is a difference between the mean postoperative pain after using double antibiotic paste versus calcium hydroxide in teeth with symptomatic apical periodontitis.

Official title: Comparison of Mean Postoperative Pain After Using Double Antibiotic Paste Versus Calcium Hydroxide as an Intracanal Medicament in Teeth With Symptomatic Apical Periodontitis: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

16 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

662

Start Date

2025-09-05

Completion Date

2026-10-05

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DRUG

Calcium Hydroxide (Ca(OH)2)

Calcium hydroxide is a widely used intracanal medicament in endodontic treatment. It is a strong base with a high pH (approximately 12.5) that exhibits antibacterial activity against a broad spectrum of microorganisms. It is used to disinfect the root canal system, reduce residual bacteria after chemo-mechanical preparation, minimize postoperative inflammation, and address pain. In this study, calcium hydroxide will be placed into the root canals after chemo-mechanical preparation and drying with absorbent paper points. The access cavity will be sealed with temporary restorative material containing cotton pellets. The medicament will remain in the canal until the next appointment.

DRUG

Double Antibiotic Paste

Double antibiotic paste (DAP) is a mixture of metronidazole and ciprofloxacin. It is employed as an intracanal antibiotic to disinfect necrotic teeth. Its effectiveness has been demonstrated in reducing bacterial counts within infected root canals. In this study, DAP will be prepared by combining the contents of one FLAGYL® (metronidazole) 500 mg tablet and one Cipesta™ (ciprofloxacin) 500 mg tablet in a precise volume of normal saline to make a homogeneous paste. The paste will be placed into the root canals after chemo-mechanical preparation and drying with absorbent paper points. The access cavity will be sealed with temporary restorative material containing cotton pellets. The medicament will remain in the canal until the next appointment.

Locations (1)

Saidu College of dentistry,Swat

Swāt, Kpk, Pakistan