NCT05349929

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)

Comparison of the Analgesic Effect of Bromelain and Ibuprofen on Pain After Root Canal Treatment(A Clinical Trial Study)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Qazvin University Of Medical Sciences · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
DRUG	Gelofen (generic name of Ibuprofen in Iran)	Gelofen capsules, 400mg Ibuprofen, Dana pharma company, every 6hours
DRUG	Anahil ( generic name of Bromelain in Iran)	Anahil capsules,200 mg Bromelain, Permon Amin Health Company,every 6hours
PROCEDURE	Root Canal Therapy	all the participants go under RCT.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2022-04-27
• Last updated: 2022-04-27