- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07759349
Comparison Of Acetaminophen, NSAIDs, And Trypsin-Chymotrypsin Plus Acetaminophen For Post-Endodontic Pain After Single-Visit Root Canal Treatment
15. august 2026 opdateret af: Kanchan Devi, Dow University of Health Sciences
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
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).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
90
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dr. Kanchan Devi Dr. Kanchan Devi, Bachelor In Dental Surgery
- Telefonnummer: 092333-2972137
- E-mail: kanchanharmit@gmail.com
Studiesteder
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75600
- Rekruttering
- Dow University of Health Sciences
-
Kontakt:
- Dr. Kanchan Devi Dr. Kanchan Devi, Bachelor In Dental Surgery
- Telefonnummer: 092333-2972137
- E-mail: kanchanharmit@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Acetaminophen Group (Group A)
500 mg orally, three times daily after meals for 3 days following completion of single-visit endodontic treatment.
|
500 mg orally, three times daily after meals for 3 days following completion of single-visit endodontic treatment
|
|
Aktiv komparator: NSAID Group (Group B)
600 mg orally, three times daily, 1 hour before meals for 3 days following completion of treatment
|
600 mg orally, three times daily, 1 hour before meals for 3 days following completion of treatment
|
|
Eksperimentel: Trypsin-Chymotrypsin + Acetaminophen Group (Group C)
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.
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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"
Tidsramme: 6, 12, 24, 48, and 72 hours
|
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
|
6, 12, 24, 48, and 72 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
2. august 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
7. august 2026
Først indsendt, der opfyldte QC-kriterier
7. august 2026
Først opslået (Faktiske)
12. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Anti-inflammatoriske midler
- Agenter fra det perifere nervesystem
- Antirheumatiske midler
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Analgetika
- Organiske kemikalier
- Farmakologiske handlinger
- Kemiske handlinger og anvendelser
- Terapeutiske anvendelser
- Anilider
- Amider
- Anilinforbindelser
- Aminer
- Acetanilider
- Acetaminophen
- Anti-inflammatoriske midler, ikke-steroide
- chymotrypsin, trypsin drug combination
Andre undersøgelses-id-numre
- IRB4334/DUHS/Approval/2025/227
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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