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Analgesic Effect of Anahil and Ibuprofen on Pain After Root Canal Therapy in Patients With Pulpitis of the Molars in Qazvin(a City in Iran)

Primary Purpose

Irreversible Pulpitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gelofen (generic name of Ibuprofen in Iran)
Anahil ( generic name of Bromelain in Iran)
Root Canal Therapy
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Ibuprofen

    Anahil

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    pain severity
    Visual Analogue Scale
    pain severity
    Visual Analogue Scale
    pain severity
    Visual Analogue Scale
    pain severity
    Visual Analogue Scale
    pain severity
    Visual Analogue Scale
    need of supplemental dosage of Ibuprofen
    By asking the numbers of consuming capsules
    need of supplemental dosage of Ibuprofen
    By asking the numbers of consuming capsules
    need of supplemental dosage of Ibuprofen
    By asking the numbers of consuming capsules
    need of supplemental dosage of Ibuprofen
    By asking the numbers of consuming capsules

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2022
    Last Updated
    April 22, 2022
    Sponsor
    Qazvin University Of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05349929
    Brief Title
    Analgesic Effect of Anahil and Ibuprofen on Pain After Root Canal Therapy in Patients With Pulpitis of the Molars in Qazvin(a City in Iran)
    Official Title
    Comparison of the Analgesic Effect of Bromelain and Ibuprofen on Pain After Root Canal Treatment(A Clinical Trial Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qazvin University Of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Patients will be selected from those who are referred to receive root canal therapy for the mandibular first molars with irreversible pulpitis. The current research and all the procedures will be done in a private dental clinic in Qazvin, Iran by a single endodontist. 72 Patients who will meet our study demands and criteria would be qualified to enter the study and will sign the informed consent form explaining the study circumstances and its possible risks. Patient information sheet includes dental, medical and drug history and demographic information will be obtained as well. Radiographic examination includes the amount of caries, root curvature, periapical and hard tissue situation, dental pulp vitality tests including Electrical Pulp Test(EPT) and thermal tests (heat and cold) and periapical tests consisting of percussion and palpation would be recorded. The patients would be divided randomly in Ibuprofen and Anahil groups, these drugs would be put in the same shape and appearance by a pharmacist and named as A and B respectively. Anahil capsules containing 200 mg of bromelain, Permon-Amin Health Company, Gelofen 400mg capsules, Dana-Pharma company:The pre procedure pain of the patients would be asked and recorded by Visual Analogue Scale(VAS), a 100 mm long ruler which has no numeration by means of enhancing the accuracy and minimizing the failure. Standard Infra alveolar nerve(IAN) direct block will be done by injection of 1.8ml of lidocaine 2% containing 1:100000 epinephrine with a long 32mm gauge 27 needle. The efficiency of Inferior Alveolar Nerve block injection will be examined with the numbness of inferior lip. Supplementary anesthesia (like intrapulpal or Periodontal Ligament(PDL) anesthesia) will be used if the pain is still remained after 15 minutes. After tooth isolation with rubberdam, caries removal, access cavity and tooth preparation will be done. Length determination will be performed with the help of periapical radiography and apex locator. Cleaning and shaping will be done. Normal Saline and hypochlorite 2% will be used as intracanal irrigants. The canals will then be dried and gutted laterally with gutta-percha and AH+ sealer. A cotton pellet will be placed in the access cavity. Temporary restoration will be applied after occlusal reduction and the occlusion will be checked. No intracanal medicament will be placed. In this triple blinded study, patients will be given A and B drugs (36 patients in each group, equal in gender) with medications order randomly and will be followed 6, 12, 24 and 48 hours after endodontics treatment to report the pain score with VAS and the number of supplementary dosage of Ibuprofen with the time that they have consumed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irreversible Pulpitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ibuprofen
    Arm Type
    Experimental
    Arm Description
    Ibuprofen(Gelofen) 400mg capsules, Dana pharma company, every 6hours
    Arm Title
    Anahil
    Arm Type
    Experimental
    Arm Description
    Bromelain(Anahil) 200 mg capsules, Permon Amin Health Company,every 6hours
    Intervention Type
    Drug
    Intervention Name(s)
    Gelofen (generic name of Ibuprofen in Iran)
    Intervention Description
    Gelofen capsules, 400mg Ibuprofen, Dana pharma company, every 6hours
    Intervention Type
    Drug
    Intervention Name(s)
    Anahil ( generic name of Bromelain in Iran)
    Intervention Description
    Anahil capsules,200 mg Bromelain, Permon Amin Health Company,every 6hours
    Intervention Type
    Procedure
    Intervention Name(s)
    Root Canal Therapy
    Intervention Description
    all the participants go under RCT.
    Primary Outcome Measure Information:
    Title
    pain severity
    Description
    Visual Analogue Scale
    Time Frame
    0 hour (before root canal treatment)
    Title
    pain severity
    Description
    Visual Analogue Scale
    Time Frame
    6 hours after root canal treatment
    Title
    pain severity
    Description
    Visual Analogue Scale
    Time Frame
    12 hours after root canal treatment
    Title
    pain severity
    Description
    Visual Analogue Scale
    Time Frame
    24 hours after root canal treatment
    Title
    pain severity
    Description
    Visual Analogue Scale
    Time Frame
    48 hours after root canal treatment
    Title
    need of supplemental dosage of Ibuprofen
    Description
    By asking the numbers of consuming capsules
    Time Frame
    6 hours after root canal treatment
    Title
    need of supplemental dosage of Ibuprofen
    Description
    By asking the numbers of consuming capsules
    Time Frame
    12 hours after root canal treatment
    Title
    need of supplemental dosage of Ibuprofen
    Description
    By asking the numbers of consuming capsules
    Time Frame
    24 hours after root canal treatment
    Title
    need of supplemental dosage of Ibuprofen
    Description
    By asking the numbers of consuming capsules
    Time Frame
    48 hours after root canal treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona Esfahani, Student
    Phone
    +989120407509
    Email
    monaes2424@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mahsa Esfehani, Ms
    Organizational Affiliation
    associate professor of oral medicine of Qazvin University Of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Analgesic Effect of Anahil and Ibuprofen on Pain After Root Canal Therapy in Patients With Pulpitis of the Molars in Qazvin(a City in Iran)

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