A Phase 4 interventional study of Calcium Hydroxide (CH) and Triple Antibiotic Paste in Apical Periodontitis, Pulp Necrosis and Postoperative Pain, sponsored by Rehman Medical Institute - RMI. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Rehman Medical Institute - RMI · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn whether triple antibiotic paste reduces pain after root canal treatment more than calcium hydroxide in adults aged 18 to 70 years who have a dead (necrotic) tooth with painful infection at the root tip (symptomatic apical periodontitis). The main question it aims to answer is:
Does placing triple antibiotic paste inside the root canal lower pain 72 hours after treatment compared with calcium hydroxide?
Researchers will compare triple antibiotic paste (a mix of three antibiotics: ciprofloxacin, metronidazole and minocycline) with calcium hydroxide, the medicine most commonly placed inside root canals between dental visits, to see which one leads to less pain after treatment.
Participants will Receive root canal cleaning and shaping of the affected tooth Have either calcium hydroxide or triple antibiotic paste placed inside the root canal, decided by chance Rate their pain on a 0 to 10 scale 72 hours after treatment
Pain after root canal treatment is common in teeth with symptomatic apical periodontitis and is linked to bacteria and their by-products remaining in the complex root canal system. Calcium hydroxide is widely used as an inter-appointment intracanal medicament because of its high alkalinity and antibacterial action, but some bacteria commonly found in infected root canals are resistant to it. Triple antibiotic paste combines ciprofloxacin, metronidazole and minocycline. Together they act against Gram-positive, Gram-negative and anaerobic bacteria, which may reduce the remaining bacterial load and periapical inflammation more effectively.
This is a two-arm, parallel-group randomized clinical trial conducted at the Department of Operative Dentistry and Endodontics, Rehman Medical Institute, Peshawar, Pakistan. Patients are recruited consecutively. Written informed consent is obtained from each patient or guardian. Baseline age, sex, tooth treated and preoperative pain are recorded on a standardized proforma.
Participants are allocated in a 1:1 ratio to the calcium hydroxide group (Group A) or the triple antibiotic paste group (Group B) by permuted block randomization with a block size of 4. The sequence is computer-generated. Allocation is concealed in sequentially numbered, opaque, sealed envelopes opened only after the patient's enrolment.
All teeth receive the same treatment under local anaesthesia and rubber dam isolation. The working length is set with an electronic apex locator and confirmed radiographically. Canals are cleaned and shaped with a rotary nickel-titanium system (ProTaper Gold, Dentsply Sirona) and irrigated with 2.5% sodium hypochlorite. The smear layer is removed with 17% EDTA for 1 minute, followed by a final saline rinse, to improve penetration of the medicament into dentinal tubules. Canals are dried with paper points.
Group A receives calcium hydroxide paste (Metapex or equivalent commercial preparation). Group B receives triple antibiotic paste made from ciprofloxacin, metronidazole and minocycline in a 1:1:1 ratio, mixed with propylene glycol to a creamy consistency. The medicament is placed with a lentulo spiral to working length, and the access cavity is sealed with a sterile cotton pellet and a temporary restoration (Cavit, 3M ESPE). The medicament stays in place for 7 days until the next appointment.
Pain is recorded by the patient on a 0 to 10 Visual Analog Scale at 72 hours after treatment and grouped as no pain (0), mild (1 to 3), moderate (4 to 6) or severe (7 to 10). The sample size of 138 patients (69 per group) was calculated with reference to Narayanan et al. (2022). Data are analysed in SPSS. Mean pain scores are compared between groups with the independent-samples t-test, and pain categories with the chi-square test. Pain category is also stratified by age and gender. A p-value below 0.05 is considered significant.
Your manuscript lists these as two separate steps: EDTA rinse and then medicament placement. Paste the next set of form questions when you reach them.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's enrollment of 138 is above the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Rehman Medical Institute - RMI is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received calcium hydroxide paste as the intracanal medicament after cleaning, shaping and EDTA smear-layer removal. The paste was left in the canal for 7 days.
Drug: Calcium Hydroxide (CH)
Participants received triple antibiotic paste (ciprofloxacin, metronidazole and minocycline, 1:1:1, mixed with propylene glycol) as the intracanal medicament after cleaning, shaping and EDTA smear-layer removal. The paste was left in the canal for 7 days.
Drug: Triple Antibiotic Paste
Calcium hydroxide paste placed in the root canal with a lentulo spiral to working length as an inter-appointment intracanal medicament.
Drug pages: Ciprofloxacin · Metronidazole · Minocycline
Equal parts ciprofloxacin, metronidazole and minocycline mixed with propylene glycol, placed in the root canal with a lentulo spiral to working length as an inter-appointment intracanal medicament.
Postoperative Pain Intensity
Pain intensity was self-reported by participants on a 0 to 10 Visual Analog Scale, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain. Mean scores were compared between the calcium hydroxide and triple antibiotic paste groups.
Time frame: 72 hours after treatment
Postoperative Pain Severity Category
Number of participants in each pain category, based on the 0 to 10 Visual Analog Scale score: no pain (0), mild (1 to 3), moderate (4 to 6) and severe (7 to 10). Proportions were compared between groups.
Time frame: 72 hours after treatment
Plan to share: No
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Studies of the drugs tested here: Ciprofloxacin · Metronidazole · Minocycline
Rehman Medical Institute - RMI