An interventional study of Calcium Hydroxide (20%) and Chlorhexidine Gel (2%) in Periodontal Diseases, sponsored by HITEC-Institute of Medical Sciences. Completed at 1 site in Pakistan. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by HITEC-Institute of Medical Sciences · Not applicable, Interventional, and Treatment
Comparison of different intracanal medicaments during root canal treatment to assess their effect on post-operative pain in teeth with Symptomatic Apical Periodontitis
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:
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.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's enrollment of 480 is above the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
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Exclusion Criteria:
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.
Drug: Calcium Hydroxide (20%)
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.
Drug: Chlorhexidine Gel (2%)
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.
Drug: Modified Triple Antibiotic Paste
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.
Also known as: Modified triple antibiotic paste
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.
Also known as: Calcium hyroxide
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.
Also known as: Chlorhexidine
Post-operative Pain Intensity Measured Using the Wong-Baker FACES Pain Rating Scale (WFPRS)
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. Units of Measurement: Score range: 0-10 (intervals of 2)
Time frame: At baseline (0 hours), 6 hours, 24 hours, and 48 hours post-operatively
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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HITEC-Institute of Medical Sciences