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.
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.
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.
Parallel
Calcium Hydroxide (Ca(OH)2)
DrugCalcium 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
DrugDouble 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.
Mean Postoperative Pain Score at 24 Hours Assessed Using 10-Point Visual Analog Scale (VAS)
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
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