RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: College of Physicians and Surgeons Pakistan • ClinicalTrials.gov ID: NCT07867951

Registry updated: 2026-10-09

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Calcium Hydroxide (Ca(OH)2) (Drug)
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.
Double Antibiotic Paste (Drug)
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.

Eligibility criteria

Inclusion Criteria:1. Patients with ages ranging from 16 to 50 years. 2. Teeth diagnosed with symptomatic apical periodontitis clinically by percussion and radiographically by the presence of radiolucency around the tooth apex. 3\. Patients with good general health (no medical condition). \- Exclusion Criteria: * 1\. Pregnant women. 2. Patients who had received antibiotic treatment during the last 3 months. 3. Patients having more than one tooth requiring root canal treatment. 4. Teeth with periodontal probing depth \>4 mm measured with W.H.O probe. 5. Teeth that couldn't be isolated with a rubber dam. 6. Teeth with previous root canal treatment, or teeth with fluctuant facial swelling where emergency management should include incision and drainage.

Conditions

Symptomatic Apical Periodontitis

Locations

Saidu College of dentistry,Swat — Swāt, Kpk, Pakistan

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment