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Comparison of the analgesic effect of Anahil Plus and ibuprofen on pain after root canal treatment: a clinical trial study

Protocol summary

Study aim
Evaluation of analgesic effect of ibuprofen and Anahil Plus on postendodontic pain
Design
A clinical trial with parallel, single-blind, randomized, phase 2-3 groups on 78 patients. The process of randomization is done by Random allocation software.
Settings and conduct
the control group receives ibuprofen tablets and the intervention group receives Anahil Plus capsules. infra alveolar nerve block is done by injection of 1.8ml of lidocaine. After tooth isolation, tooth preparation will be done. Length determination is performed with the help of periapical radiography. Cleaning and shaping are done using the passive step-back technique. Saline and hypochlorite 2% are used as a cleanser. The canals are then dried with a paper cone and gutted laterally with gutta-percha and AH26 sealer. Patients are asked to record the pain score before drug use, 6, 12, and 24 hours after endo treatment. all steps are done in a private clinic.
Participants/Inclusion and exclusion criteria
inclusion criteria: Healthy patients aged 20 to 50 years with posterior teeth with irreversible pulpitis, radiographically normal teeth without any lesions exclusion criteria: Patients using a drug that interferes with NSAIDs or lidocaine, systemic disease, pregnancy or lactation, allergy to Pineapple, celery, carrot, and fennel, aggressive periodontal disease, irreparable teeth
Intervention groups
control group includes 39 patients receiving ibuprofen 400mg tablets, saponin company, single-dose before endodontic treatment; intervention group includes 39 patients receiving Anahil Plus capsules containing 150 mg of bromelain and 300 mg of turmeric, Permon Amin Health Company, single-dose before endodontic treatment
Main outcome variables
Pain intensity after treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200905048627N1
Registration date: 2020-10-16, 1399/07/25
Registration timing: registered_while_recruiting

Last update: 2020-10-16, 1399/07/25
Update count: 0
Registration date
2020-10-16, 1399/07/25
Registrant information
Name
Fateme Keshvardoost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3340 5474
Email address
f.keshvardoost@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-19, 1399/06/29
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of Anahil Plus and ibuprofen on pain after root canal treatment: a clinical trial study
Public title
effect of Anahil Plus and Ibuprofen on pain after root canal treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients aged 20 to 50 years Posterior teeth with irreversible pulpitis Spontaneous pain with at least 30mm on Visual Analogue Scale Radiographically normal teeth, without any lesions, without sinus tract and without acute periapical abscess Normal patients according to the Hospital Anxiety and Depression Scale Prolonged tooth response to pulp electrical test and Endo-ice test Fill in and sign the consent form
Exclusion criteria:
Taking medication that interferes with Non Steroid Anti Inflammatory Drugs or Lidocaine Existence of systemic disease Pregnancy or breastfeeding allergy to pineapple, celery, carrot and fennel Consumers of anticoagulants Existence of aggressive periodontal disease unable to restore the tooth pain in more than one tooth
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is 2-step. In the first step, using a simple random sampling method, samples with inclusion criteria will be selected. In the second stage, the blocked randomization method will be used for random allocation. Using blocked randomization, samples are assigned to two groups. The blocked randomization process is done with random allocation software. The samples will be placed in thirteen hexagonal blocks as mentioned.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the type of medication, there is no possibility of double-blinding, so the person who records the pain score is blinded without knowing the type of medication.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vali-asr Highway, Imam Square, Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-09-06, 1399/06/16
Ethics committee reference number
IR.MAZUMS.REC.1399.601

Health conditions studied

1

Description of health condition studied
Post endodontic pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain after endodontic treatment
Timepoint
6, 12 and 24 hours after endodontic treatment
Method of measurement
Visual Analouge Scale questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Anahil Plus capsules containing 150 mg of bromelain and 300 mg of turmeric, Permon Amin Health Company, single dose before endodontic treatment
Category
Treatment - Drugs

2

Description
Control group: Ibuprofen 400 mg tablet Saponin company single dose before endodontic treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
private dental office
Full name of responsible person
Dr Narges Hoshyari
Street address
Ghoo medical complex, gharan St, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3331 5114
Email
narjeshoshyari@rocketmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Research and Technology Center, Moallem SQ, Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3326 1244
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Keshvardoost
Position
dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tooba dental clinic, khazar Blv, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
F.keshvardoost@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Narges Hoshyari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tooba dental clinic, khazar Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
narjeshoshyari@rocketmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Keshvardoost
Position
dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tooba dental clinic, khazar Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
f.keshvardoost@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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