[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659658":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":25,"studyPopulation":11,"armGroups":26,"interventions":39,"overallOfficials":11,"centralContacts":49,"locations":55,"responsibleParty":66,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"College of Physicians and Surgeons Pakistan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Mean Postoperative Pain Score at 24 Hours Assessed Using 10-Point Visual Analog Scale (VAS)",null,"24 hours after treatment",{"measure":10,"description":14,"timeFrame":15},"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.\n\nThe 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).\n\nPain scores will be compared between the two groups using student t-test or Mann-Whi","24 hours after the procedure",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":21,"maskingDescription":11,"whoMasked":22},"DOUBLE",[23,24],"PARTICIPANT","OUTCOMES_ASSESSOR","Background:\n\nPain is a primary symptom of numerous medical and dental conditions that can greatly impact an individual's overall well-being. The frequency of pain following endodontic treatment varies widely across studies, with some reporting rates as low as 3% and others as high as 58%. The success and acceptance of endodontic treatment hinge greatly on its pain-free nature. Consequently, effective pain management stands as a pivotal element throughout endodontic procedures.\n\nIn endodontic treatment, the goal is to remove as many bacteria as possible from the root canal system and reduce the risk of reinfection. Chemo-mechanical preparation is crucial in eliminating bacteria, necrotic tissues, and infected dentin. However, various instrumentation systems result in an unpredictable range, leaving 2.6% to 80% of the root canal walls untouched. Therefore, instrumentation, irrigation, and obturation cannot reliably ensure the complete elimination of bacteria from the canals, and some residual bacteria may persist in untouched areas.\n\nThe effectiveness of endodontic treatment for teeth with apical periodontitis relies significantly on successfully eradicating or greatly reducing intracanal bacteria. To ensure the destruction of any remaining germs after chemical-mechanical preparation, antibacterial intracanal medicaments are recommended. Various intracanal medicaments are employed in dentistry for diverse purposes, including reducing residual bacteria after root canal instrumentation, minimizing postoperative inflammation, and effectively addressing pain.\n\nThe double antibiotic paste is a blend of metronidazole and ciprofloxacin employed as an intracanal antibiotic to disinfect necrotic teeth. Its effectiveness has been demonstrated in reducing bacterial counts within infected root canals. Abouelenien et al. conducted a study to evaluate postoperative pain after using calcium hydroxide versus double antibiotic paste. In group A (calcium hydroxide group), the median (range) postoperative pain at 24-hour follow-up was 1 (0-9). In group B (double antibiotic paste group), the median (range) postoperative pain at 24-hour follow-up was 0.5 (0-8).\n\nGiven the diversity in opinions and practices among dental professionals in Khyber Pakhtunkhwa (KPK), Pakistan, concerning intracanal medicaments for symptomatic apical periodontitis, a notable divide exists between those favoring double antibiotic paste (DAP) and those inclined towards calcium hydroxide. This disparity underscores the need for a comprehensive investigation into the comparative efficacy of these treatments, particularly concerning post-operative pain reduction-an issue of paramount concern for individuals undergoing dental procedures.\n\nObjective:\n\nTo compare the mean postoperative pain after using double antibiotic paste versus calcium hydroxide in teeth with symptomatic apical periodontitis.\n\nHypothesis:\n\nThere is a difference between the mean postoperative pain after double antibiotic paste versus calcium hydroxide in teeth with symptomatic apical periodontitis.\n\nMethods:\n\nStudy Design: Randomized Controlled Trial.\n\nStudy Setting: Operative \\& Endodontic Department, Saidu College of Dentistry, Swat, Pakistan.\n\nDuration of Study: Minimum of six months after the approval of synopsis from CPSP.\n\nSample Technique: Consecutive (non-probability) technique.\n\nSample Size: 662 patients (331 per group) calculated with OpenEpi at 95% confidence interval, 80% power of test using mean pain at 24 hours to be 2.099 ± 2.47 in calcium hydroxide group and 1.59 ± 2.19 in double antibiotic paste group from the previous study. The previous study did not report the values such as mean and SD required for sample size determination, so the available values (minimum, maximum, median, and sample size) were converted into mean and SD using a calculator based on the methodologies presented by Luo et al. (2018) and Wan et al. (2014).\n\nInclusion Criteria:\n\n1. Patients with ages ranging from 16 to 50 years.\n2. Teeth diagnosed with symptomatic apical periodontitis clinically by percussion and radiographically by the presence of radiolucency around the tooth apex.\n3. Patients with good general health (no medical condition).\n\nExclusion Criteria:\n\n1. Pregnant women.\n2. Patients who had received antibiotic treatment during the last 3 months.\n3. Patients having more than one tooth requiring root canal treatment.\n4. Teeth with periodontal probing depth \\>4 mm measured with W.H.O probe.\n5. Teeth that couldn't be isolated with a rubber dam.\n6. Teeth with previous root canal treatment, or teeth with fluctuant facial swelling where emergency management should include incision and drainage.\n\nData Collection Procedures:\n\nApproval of the hospital ethical review committee of Saidu College of Dentistry will be taken. Patients will be informed about the study's purpose, procedure, and benefits. An informed consent both oral and written will be taken for willingness and participation in this study. The patients will be assured regarding maintaining the confidentiality of their personal and other data collected from their records.\n\nBefore initiating endodontic treatment, 662 consecutive first-time patients aged 16 to 50 years who present at the Operative Dentistry Department of Saidu College of Dentistry will complete a questionnaire-based history and undergo a clinical examination, radiographic examination, and diagnostic test (clinical symptoms involving a painful response to biting and\u002For percussion or palpation and radiographically by widening of periodontal ligament space) to evaluate the symptomatic apical periodontitis, and will be documented in proforma.\n\nParticipants will be randomly divided into two groups by lottery method. Group A will receive calcium hydroxide and Group B will receive double antibiotic paste. Each patient will mark the pain on a Visual Analog Scale (VAS) questionnaire as numeric value. All this data will be recorded in proforma following inclusion and exclusion criteria.\n\nAfter local anesthetic (HD CAINE plus inj- 2% lidocaine hydrochloride with adrenaline 1:100,000) has been applied, the tooth that needs treatment will be isolated using a rubber dam. Using a high-speed handpiece, an access cavity will be made where the carious lesion is (this process is known as access opening). After locating the root canal orifices, the pulpectomy operation will be performed using manual hand K files (Mani-K Files). As decided by radiography and tactile perception, the working length will now be measured just 1 mm short of the apex. During this appointment, the chemo-mechanical preparation will also be completed. The Step Back technique will be used to clean and shape the canals after the working length has been determined. To eliminate all the debris, irrigation with 3% sodium hypochlorite (Tehno Dent - Antiseptic Liquid - Sodium Hypochlorite) will be done occasionally. To avoid the formation of a smear layer, 17% EDTA (PD - EDTA 17% Gel) will be used. After one minute, the canal will be cleaned with ordinary saline solution. Before inserting intracanal drugs, the canals will be dried with absorbent paper points (Meta BioMed). The access cavity will now be filled with temporary restorative material that contains cotton pellets, and the root canals will now be filled with intracanal medicament. After 1 hour and at 24 hours following therapy, the patient will be questioned about their level of pain on cell phones.\n\nStatistical Analysis:\n\nStatistical analysis will be done in SPSS 24. Mean and standard deviation will be calculated for age and pain score (VAS score) numeric data. Frequency and percentages will be completed for categorical data like gender. Pain score will be compared between two groups using student t-test or Mann-Whitney U test (if skewed assessed by Shapiro-Wilk test). Stratification will be done with respect to gender and age group to see effect modifiers. Post-stratification student t-test or Mann-Whitney U test (if skewed assessed by Shapiro-Wilk test) will be performed for pain type and a score P ≤ 0.05 will be significant.\n\nOutcome Measures:\n\nPrimary Outcome: Mean postoperative pain measured on a 10-point Visual Analog Scale (VAS) at 24 hours after treatment.\n\nSecondary Outcome: Mean postoperative pain measured on a 10-point Visual Analog Scale (VAS) at 1 hour after treatment.",[27,34],{"label":28,"type":29,"description":30,"interventionNames":31},"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.",[32,33],"Drug: Calcium Hydroxide (Ca(OH)2)","Drug: Double Antibiotic Paste",{"label":35,"type":36,"description":37,"interventionNames":38},"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.",[32,33],[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"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.",[28,35],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"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.",[28,35],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Jamal Ahad","CONTACT","03329475002","jamalkha230@gmail.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":11,"country":61,"countryCode":62,"cosmosGeoPoint":11,"geoPoint":11,"contacts":63},"Saidu College of dentistry,Swat","RECRUITING","Swāt","Kpk","Pakistan","PK",[64],{"name":51,"role":52,"phone":65,"phoneExt":11,"email":54},"03451505838",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Faiz ur rahman","Assistant proffessor","100659658","comparison-of-postoperative-pain-after-double-antibiotic-paste-vs-calcium-hydroxide-in-teeth-with-symptomatic-apical-periodontitis-100659658",false,"NCT07867951","Comparison of Postoperative Pain After Double Antibiotic Paste vs Calcium Hydroxide in Teeth With Symptomatic Apical Periodontitis","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","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.\n\n3\\. Patients with good general health (no medical condition).\n\n\\-\n\nExclusion Criteria:\n\n* 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.","ALL","16 Years","50 Years",{"count":81,"type":82},662,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.\n\nSymptomatic 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.\n\nPatients 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).\n\nPostoperative 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.\n\nThe 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.",[88],"Symptomatic Apical Periodontitis",[90,91,92],"Apical Periodontitis","Postoperative Pain","Double antibiotic paste","2026-10-05",{"date":95,"type":96},"2026-10-09","ACTUAL",{"date":98,"type":96},"2025-09-05",{"date":93,"type":82},{"name":5,"class":6},1]