Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT07123792
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intracanal Medicaments on Post-Operative Pain in Symptomatic Apical Periodontitis: An RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002126', 'term': 'Calcium Hydroxide'}, {'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Pain Intensity Measured Using the Wong-Baker FACES Pain Rating Scale (WFPRS)', 'timeFrame': 'At baseline (0 hours), 6 hours, 24 hours, and 48 hours post-operatively', 'description': "Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale (WFPRS), a validated 6-point facial expression scale. The scale ranges from 0 (no pain) to 10 (worst pain), with corresponding facial images used to help patients subjectively rate their pain. This tool will be used during follow-up calls to determine the patient's level of pain after root canal instrumentation and medicament placement.\n\nUnits of Measurement:\n\nScore range: 0-10 (intervals of 2)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '36833788', 'type': 'BACKGROUND', 'citation': 'Khan AM, Gangoo IKA, Ali NA, Khan M, Javed MQ, AlAttas MH, Abulhamael AM, Bahammam HA, Alsofi L, Yahya RSA. The Effect of Calcium Hydroxide, Triple Antibiotic Paste and Chlorhexidine on Pain in Teeth with Symptomatic Apical Periodontitis: A Randomised Controlled Trial. Int J Environ Res Public Health. 2023 Feb 10;20(4):3091. doi: 10.3390/ijerph20043091.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of different intracanal medicaments during root canal treatment to assess their effect on post-operative pain in teeth with Symptomatic Apical Periodontitis', 'detailedDescription': 'Pain is the most common clinical symptom associated with endodontic treatment. Symptomatic apical periodontitis (SAP) results in significant post-operative discomfort due to microbial invasion and inflammatory changes in periapical tissues. Intracanal medicaments are used to reduce microbial load and inflammation between treatment appointments, potentially reducing post-treatment pain. This study investigates the comparative effectiveness of three commonly used intracanal medicaments in reducing pain following biomechanical preparation:\n\nGroup 1: Calcium hydroxide (CH)\n\nGroup 2: Chlorhexidine gel (CHX 2%)\n\nGroup 3: Modified Triple Antibiotic Paste (TAP) - a combination of ciprofloxacin, clindamycin, and metronidazole in 1:1:1 ratio\n\nA total of 480 participants with single-rooted teeth diagnosed with symptomatic apical periodontitis will be randomly assigned into three groups (160 in each group). Endodontic treatment will be performed by a single operator under standard protocols. No systemic analgesics or antibiotics will be prescribed. Pain assessment will be done using the Wong-Baker FACES Pain Rating Scale (0-10), and recorded at baseline (0 h), 6 h, 24 h, and 48 h after treatment.\n\nThe study aims to provide evidence on the most effective intracanal medicament to minimize post-operative pain, improving patient outcomes and guiding clinical decision-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single rooted teeth (Anterior or posterior)\n* Teeth with acute symptomatic apical periodontitis\n\nExclusion Criteria:\n\n* Non-restorable teeth, presence of endo-perio lesions, teeth with acute or chronic apical abcess, teeth with internal/external root resorption\n* Teeth with anatomical difficulties like open apices, calcified canals, dilacerations\n* Patients with parafunctional habits\n* Patients who were allergic to medications that were used in the study\n* Patients who were taking medicines that could influence pain perception\n* Patients that had any serious medical illness or with systemic disorders'}, 'identificationModule': {'nctId': 'NCT07123792', 'briefTitle': 'Effect of Intracanal Medicaments on Post-Operative Pain in Symptomatic Apical Periodontitis: An RCT', 'organization': {'class': 'OTHER', 'fullName': 'HITEC-Institute of Medical Sciences'}, 'officialTitle': 'Comparison of Different Intracanal Medicaments on Post-operative Pain in Teeth With Symptomatic Apical Periodontitis: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'Dr Fatimah'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcium Hydroxide group', 'description': 'Participants in this group will receive 20% calcium hydroxide paste as the intracanal medicament after root canal instrumentation. The medicament will be placed using a Lentulo spiral, excess removed from the chamber, and the tooth sealed with glass ionomer cement. Pain will be assessed at 0, 6, 24, and 48 hours postoperatively.', 'interventionNames': ['Drug: Calcium Hydroxide (20%)']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine group', 'description': 'Participants in this group will receive 2% chlorhexidine gel as the intracanal medicament following canal preparation. It will be placed with a Lentulo spiral and sealed in the same manner. Postoperative pain will be evaluated at the same intervals.', 'interventionNames': ['Drug: Chlorhexidine Gel (2%)']}, {'type': 'EXPERIMENTAL', 'label': 'Modified triple antibiotic paste', 'description': 'Participants in this group will receive a modified triple antibiotic paste made from ciprofloxacin, metronidazole, and clindamycin in a 1:1:1 ratio by weight. The paste will be placed inside the canal using a Lentulo spiral and sealed as per protocol. Pain will be recorded at 0, 6, 24, and 48 hours post-treatment.', 'interventionNames': ['Drug: Modified Triple Antibiotic Paste']}], 'interventions': [{'name': 'Calcium Hydroxide (20%)', 'type': 'DRUG', 'otherNames': ['Modified triple antibiotic paste'], 'description': 'A 20% calcium hydroxide paste will be placed as an intracanal medicament following root canal instrumentation. Applied using a Lentulo spiral, excess is removed, and the tooth is sealed with a glass ionomer temporary restoration.', 'armGroupLabels': ['Calcium Hydroxide group']}, {'name': 'Chlorhexidine Gel (2%)', 'type': 'DRUG', 'otherNames': ['Calcium hyroxide'], 'description': 'A 2% chlorhexidine gel will be used as an intracanal medicament following canal preparation. It will be delivered with a Lentulo spiral, cleaned from the chamber, and the tooth sealed.', 'armGroupLabels': ['Chlorhexidine group']}, {'name': 'Modified Triple Antibiotic Paste', 'type': 'DRUG', 'otherNames': ['Chlorhexidine'], 'description': 'A modified triple antibiotic paste consisting of ciprofloxacin, metronidazole, and clindamycin (1:1:1 by weight) will be placed in the canal using a Lentulo spiral. The excess paste will be removed, and the cavity will be sealed with temporary restorative material.', 'armGroupLabels': ['Modified triple antibiotic paste']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Dental hospial, Hitec-IMS', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Beenish Qureshi, BDS, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'HITEC-Institute of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HITEC-Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'fatimaharshad', 'investigatorAffiliation': 'College of Physicians and Surgeons Pakistan'}}}}