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
About this trial
This is an interventional treatment trial for Irreversible Pulpitis
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
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
NCT ID
NCT05349929
First Posted
April 5, 2022
Last Updated
April 22, 2022
Sponsor
Qazvin University Of Medical Sciences
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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