NCT05349929

Brief Summary

Hypothesis: 0: The analgesic effect of Ibuprofen and Anahil would be the same in reducing the pain after root canal therapy. 1: Ibuprofen shows higher potency to reduce the pain after root canal therapy. 1: Anahil shows higher potency to reduce the pain after root canal therapy. 1\. combination of the Anahil and Ibuprofen would have more effective results in reducing the pain post endodontic treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

April 5, 2022

Last Update Submit

April 22, 2022

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (9)

  • pain severity

    Visual Analogue Scale

    0 hour (before root canal treatment)

  • pain severity

    Visual Analogue Scale

    6 hours after root canal treatment

  • pain severity

    Visual Analogue Scale

    12 hours after root canal treatment

  • pain severity

    Visual Analogue Scale

    24 hours after root canal treatment

  • pain severity

    Visual Analogue Scale

    48 hours after root canal treatment

  • need of supplemental dosage of Ibuprofen

    By asking the numbers of consuming capsules

    6 hours after root canal treatment

  • need of supplemental dosage of Ibuprofen

    By asking the numbers of consuming capsules

    12 hours after root canal treatment

  • need of supplemental dosage of Ibuprofen

    By asking the numbers of consuming capsules

    24 hours after root canal treatment

  • need of supplemental dosage of Ibuprofen

    By asking the numbers of consuming capsules

    48 hours after root canal treatment

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Ibuprofen(Gelofen) 400mg capsules, Dana pharma company, every 6hours

Drug: Gelofen (generic name of Ibuprofen in Iran)Procedure: Root Canal Therapy

Anahil

EXPERIMENTAL

Bromelain(Anahil) 200 mg capsules, Permon Amin Health Company,every 6hours

Drug: Anahil ( generic name of Bromelain in Iran)Procedure: Root Canal Therapy

Interventions

Gelofen (generic name of Ibuprofen in Iran)DRUG

Gelofen capsules, 400mg Ibuprofen, Dana pharma company, every 6hours

Ibuprofen
Anahil ( generic name of Bromelain in Iran)DRUG

Anahil capsules,200 mg Bromelain, Permon Amin Health Company,every 6hours

Anahil
Root Canal TherapyPROCEDURE

all the participants go under RCT.

AnahilIbuprofen

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients report spontaneous pain of the first molar of mandible ranging from 50 to 100 mm on a VAS (0-100 mm)
  • The dental pulp's condition is irreversible pulpitis and the tooth is reparable and need the root canal therapy
  • No evidences of any lesions and lucency, PDL widening, loss of lamina dura in radiographic examination
  • Patients aged 20 to 50 years from both genders
  • Patients are not pregnant or breast-feeding
  • Healthy periodontal status (no evidences of aggressive/chronic periodontal diseases)
  • No history of any systemic diseases (specially gastrointestinal and coagulation disorders)
  • No history of allergic reaction to food nutrients (specially pineapple, celery, carrot, and fennel), NSAIDs and lidocaine
  • No history of consuming the drugs interfere with NSAIDs, lidocaine and anticoagulants
  • No use of other analgesic drugs within the last 6 hours
  • Existence of no large restorations or crowns in treated tooth
  • patients have no extreme fear of dental procedure
  • Teeth with no evidence of infection or sinus tract
  • Patients did not a previous RCT

You may not qualify if:

  • Patients who leave the study because of any reasons
  • Special anatomy of teeth (extra canals, severe root curvature, calcifications, open apex, C shape, fractures,..)
  • Patients who are not able to tolerate the single-session treatment (time, tooth's situation,..)
  • If the aspiration through IAN block injection is positive
  • If the diagnosis of pulp status has changed to partial necrosis during access cavity preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Root Canal Therapy

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Mahsa Esfehani, Ms

    associate professor of oral medicine of Qazvin University Of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Mona Esfahani, Student

CONTACT

+989120407509monaes2424@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentistry Student

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 27, 2022

Study Start

May 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04