Effect of Intracanal Medicaments on Post-Operative Pain in Symptomatic Apical Periodontitis: An RCT
NCT ID: NCT07123792
Last Updated: 2025-08-14
Study Results
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Basic Information
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COMPLETED
NA
480 participants
INTERVENTIONAL
2024-06-03
2025-06-03
Brief Summary
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Detailed Description
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Group 1: Calcium hydroxide (CH)
Group 2: Chlorhexidine gel (CHX 2%)
Group 3: Modified Triple Antibiotic Paste (TAP) - a combination of ciprofloxacin, clindamycin, and metronidazole in 1:1:1 ratio
A 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.
The study aims to provide evidence on the most effective intracanal medicament to minimize post-operative pain, improving patient outcomes and guiding clinical decision-making.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Calcium Hydroxide group
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.
Calcium Hydroxide (20%)
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.
Chlorhexidine group
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.
Chlorhexidine Gel (2%)
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.
Modified triple antibiotic paste
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.
Modified Triple Antibiotic Paste
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.
Interventions
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Calcium Hydroxide (20%)
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.
Chlorhexidine Gel (2%)
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.
Modified Triple Antibiotic Paste
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Teeth with acute symptomatic apical periodontitis
Exclusion Criteria
* Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
* Patients with parafunctional habits
* Patients who were allergic to medications that were used in the study
* Patients who were taking medicines that could influence pain perception
* Patients that had any serious medical illness or with systemic disorders
15 Years
60 Years
ALL
No
Sponsors
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HITEC-Institute of Medical Sciences
OTHER
Responsible Party
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fatimaharshad
Principal investigator
Principal Investigators
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Beenish Qureshi, BDS, FCPS
Role: STUDY_CHAIR
HITEC-Institute of Medical Sciences
Locations
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Dental hospial, Hitec-IMS
Rawalpindi, Punjab Province, Pakistan
Countries
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References
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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.
Other Identifiers
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Dr Fatimah
Identifier Type: -
Identifier Source: org_study_id
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