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

NCT07867951 | Recruiting

• 1 other identifier: DSG-2023-027-4420
• Study Type: interventional
• Target: 662
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Apical Periodontitis

Keywords

Apical Periodontitis; Postoperative Pain; Double antibiotic paste

Outcome Measures

Primary Outcomes (2)

• Mean Postoperative Pain Score at 24 Hours Assessed Using 10-Point Visual Analog Scale (VAS)

  24 hours after treatment

• Mean Postoperative Pain Score at 24 Hours Assessed Using 10-Point Visual Analog Scale (VAS)

  Postoperative pain refers to the discomfort experienced by the patient after root canal therapy. It will be measured on a 10-point Visual Analog Scale (VAS) as a numeric value, where 0 represents "no pain" and 10 represents "worst pain imaginable." Patients will be contacted by telephone to register their post-endodontic pain at 24 hours after treatment. The mean pain score will be compared between the calcium hydroxide group and the double antibiotic paste group. The sample size was calculated using mean pain at 24 hours to be 2.099 ± 2.47 in the calcium hydroxide group and 1.59 ± 2.19 in the double antibiotic paste group from a previous study (Abouelenien et al., 2018). The previous study did not report mean and SD directly; therefore, the available values (minimum, maximum, median, and sample size) were converted into mean and SD using methods described by Luo et al. (2018) and Wan et al. (2014). Pain scores will be compared between the two groups using student t-test or Mann-Whi

  24 hours after the procedure

Study Arms (2)

Calcium Hydroxide Group

EXPERIMENTAL

Participants in this arm will receive calcium hydroxide as an intracanal medicament. After chemo-mechanical preparation and drying of the root canals with absorbent paper points, calcium hydroxide paste will be placed into the root canals. The access cavity will be sealed with temporary restorative material containing cotton pellets. Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS) at 1 hour and 24 hours after treatment via telephone contact.

Drug: Calcium Hydroxide (Ca(OH)2); Drug: Double Antibiotic Paste

Double Antibiotic Paste Group

ACTIVE COMPARATOR

Participants in this arm will receive double antibiotic paste (DAP) as an intracanal medicament. 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. After chemo-mechanical preparation and drying of the root canals with absorbent paper points, the DAP will be placed into the root canals. The access cavity will be sealed with temporary restorative material containing cotton pellets. Postoperative pain will be assessed using a 10-point Visual Analog Scale (VAS) at 1 hour and 24 hours after treatment via telephone contact.

Drug: Calcium Hydroxide (Ca(OH)2); Drug: Double Antibiotic Paste

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.

Calcium Hydroxide Group; Double Antibiotic Paste Group

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.

Calcium Hydroxide Group; Double Antibiotic Paste Group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Patients with good general health (no medical condition).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

Study Sites (1)

Saidu College of dentistry,Swat

Swāt, Kpk, Pakistan

RECRUITING

Related Publications (1)

• Mantri A, Daokar S, Patil K, Wahane K, Rathi S, Sharma S. Comparative assessment of role of intracanal medicaments in pain reduction during endodontic treatment: In vivo: Visual analog scale study. J Interdiscip Dent. 2021;11(2):73.

  BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis; Pain, Postoperative

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Central Study Contacts

Jamal Ahad

CONTACT

03329475002; jamalkha230@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant proffessor

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 9, 2026
• Study Start: September 5, 2025
• Primary Completion: May 5, 2026
• Study Completion: October 5, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-09

Locations

PA (1)