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RECRUITING Early Phase 1 ClinicalTrials.gov

Comparison Of Acetaminophen, NSAIDs, And Trypsin-Chymotrypsin Plus Acetaminophen For Post-Endodontic Pain After Single-Visit Root Canal Treatment

Sponsor: Dow University of Health Sciences • ClinicalTrials.gov ID: NCT07759349

Registry updated: 2026-08-19
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Description

This randomized control trial will be planned according to PRIRATE 2020 guideline for reporting randomized trials in Endodontics. The protocol of this study will be multiple parallel arm, single blinded, randomized single centered clinical trial (allocation ratio 1:1) The study will be conducted after taking the approval from the Institutional review board (IRB), Dow University of Health Sciences (Karachi). The participants will be selected according to the inclusion and exclusion criteria and on the basis of digital peri-apical radiograph and pulp sensibility test. After taking consent (Annexure form B) from patient, cold test will be performed by applying, a cotton pellet wetted with cold spray (Endodontia) to the middle third of the buccal surface of the affected tooth. Then results of electrical test will be assessed by using a digital electric pulp tester (EPT) \[Parkell (Sybron Endo 91740)\], applying the electrode to the buccal cusp on a location close to the pulp chamber of the premolar. VAS in written form will be provided to the patients and will explain the patient about the VAS reading and how to measure the pain intensity. Afterwards, endodontic treatment will be initiated by applying topical anesthetic gel (2% Benzocaine) along with local anesthesia (2% lidocaine with 1:100 000 epinephrine). Rubber dam isolation and access cavity preparation, working length will be determined by K-10 file (MANI) and confirmed both by apex locater (J.MORITA, Dentaport Zx) and with the help of digital periapical radiograph (DIGORA). After initial canal shaping and irrigation with sodium hypochlorite (5.25%), cleaning and shaping will be done by rotary Protaper gold file (Dentsply) in sequence SX, S1, S2, F1 ,F2 till F3. Canals will be dried by corresponding paper point and obturation will be done by lateral compaction. For the obturation Protaper gold gutta percha and accessory gutta percha (ISO) will be used with sealer (Sealapex). The orfices will be sealed and permanent restoration will be done by packable composite (Ivoclar). After performing endodontic treatment the respective drug inside the sealed envelope will be randomly given to the patient and the patient will be called at 6hrs, 12hrs, 24hrs, 48hrs and 72 hrs for the determination of pain intensity and that data will be entered in data entry form(Annexure form A).

Interventions

  • Acetaminophen (Drug)
    500 mg orally, three times daily after meals for 3 days following completion of single-visit endodontic treatment
  • NSAID (Drug)
    600 mg orally, three times daily, 1 hour before meals for 3 days following completion of treatment
  • trypsin-chymotrypsin (Drug)
    Acetaminophen 500 mg orally three times daily after meals plus Trypsin 5 mg + Chymotrypsin 5 mg orally three times daily, 1 hour before meals, for 3 days after treatment

Eligibility criteria

INCLUSION CRITERIA * Both sex * Healthy ( American Society of Anesthesiologists class 1) * Age 18-60 years * Pulpal diagnosis: Symptomatic irreversible pulpitis in mandibular premolar (single canal) periapical diagnosis: symptomatic apical periodontitis * The ability of participants to understand a pain scale (VAS) Exclusion Criteria: * Pregnant females * Systemic disease and immune deficiency * Taken analgesics 24 hours, prior to treatment * Non-vital, previously initiated, previously treated teeth * Radiographic evidence of peri-radicular pathosis * Teeth with cracks, fractures and history of trauma * Developmental anomalies and immature apices * Allergic to local anesthetic solution or any experimental drugs * Patient being unable to provide informed consent.

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Locations

  • Dow University of Health Sciences — Karachi, Sindh, Pakistan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record