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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDow University of Health Sciences

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant females

Systemic disease and immune deficiency

Taken analgesics 24 hours, prior to treatment

Non-vital, previously initiated, previously treated teeth

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Acetaminophen Group (Group A)Active comparator 1 intervention
Group B: NSAID Group (Group B)Active comparator 1 intervention
Group C: Trypsin-Chymotrypsin + Acetaminophen Group (Group C)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Comparing the effect of acetaminophen, NSAIDs, trypsin-chymotrypsin + acetaminophen on post endodontic pain using visual analog scale (VAS) after single visit endodontic treatment: A randomized controlled trial"

Post-endodontic pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS) to compare the effectiveness of acetaminophen, NSAIDs, and trypsin-chymotrypsin plus acetaminophen following single-visit endodontic treatment. Pain will be recorded before treatment and at 6, 12, 24, 48, and 72 hours after treatment. Lower VAS scores indicate better pain control

Time frame
6, 12, 24, 48, and 72 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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