Periodontal Diseases
Conditions
Brief summary
Comparison of different intracanal medicaments during root canal treatment to assess their effect on post-operative pain in teeth with Symptomatic Apical Periodontitis
Detailed description
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.
Interventions
DRUGCalcium 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.
DRUGChlorhexidine 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.
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.
Sponsors
HITEC-Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Single rooted teeth (Anterior or posterior) * Teeth with acute symptomatic apical periodontitis
Exclusion criteria
* Non-restorable teeth, presence of endo-perio lesions, teeth with acute or chronic apical abcess, teeth with internal/external root resorption * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Intensity Measured Using the Wong-Baker FACES Pain Rating Scale (WFPRS) | At baseline (0 hours), 6 hours, 24 hours, and 48 hours post-operatively | 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) |
Countries
Pakistan
Outcome results
None listed