The purpose of this study is comparing two Analgesics, Ibuprofen and Anaheal after periodontal surgery. Double-blinded clinical trial is done on 22 patients who have visited period ontology part of faculty dentistry of Tabriz university of medical science, according to the inclusion criteria (patients who need Mucoperiosteal flap without bone surgery or with limited bone surgery in two half upper jaw) and exclusion criteria (asthma patient and etc.) and will be divided in two groups. In this study Ibuprofen 400 mg (control group) and Anaheal (intervention) are prescribed for patients an hour before the practice and six hours after the first dose. Drugs are packaged at Tabriz medicine faculty in the same capsules by third person in the group A and B. Open flap surgery is done on two quadrants of upper jaw with 4 weeks interval. Group A drugs are prescribed an hour before the first surgery and 6 hours after the first dose and so in the same way, patient will be consuming group B medicine for second surgery. Post-operative pain is initial outcome that will be assessed at 2, 4, 6, 8, 10, 12, 24 and 48 hours after surgery with using visual analog scale (VAS) and verbal rating scale (VRS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608301760N46
Registration date:2016-09-21, 1395/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-21, 1395/06/31
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
Expected recruitment start date
2016-08-02, 1395/05/12
Expected recruitment end date
2016-09-02, 1395/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomize Clinical trial Comparison of the effect of Ibuprofen and Anaheal on pain control after periodental surgery
Public title
Randomize Clinical trial Comparison of the effect of Ibuprofen and Anaheal on pain control after periodental surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need Mucoperiosteal flap without bone surgery or with very limited surgery of two half maxillary bones
Exclusion criteria:
During the surgery outside for 45 minutes to 60 minutes; Patients with an allergy to any drugs or other NSA-IDs Ibuprofen and Anaheal; Asthma; A history of heart disease; Pregnancy; Patients with hemophilia; Gastrointestinal diseases such as peptic ulcer diseases; Kidney disease or liver; Coagulation disorders; Patients with systemic lupus erythematosus; Patients with any history of periodontal surgery in the last six months; Patients with severe fear and anxiety when visiting the dentist; Any analgesic use during the last 48 hours;
Patients with age above 60 years; Alcohol and drugs; Total Rating Modified dental anxiety scale higher than nineteen
Age
To 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
This study is a double blind, crossover clinical trial. That project and any patient from the beginning to the final analysis, the contents of packages A and B do not know.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical sciences
Street address
Tabriz University of Medical sciences
City
Tabriz
Postal code
Approval date
2016-08-01, 1395/05/11
Ethics committee reference number
IR.TBZMED.REC.1395.496
Health conditions studied
1
Description of health condition studied
Pain after periodontal surgery
ICD-10 code
K05.5
ICD-10 code description
Other periodontal diseases
Primary outcomes
1
Description
Pain
Timepoint
At 2, 4, 6, 8, 10, 12, 24 and 48 hours after surgery
Method of measurement
Visual Analogue scale(VAS) and Verbal Rating Scale(VRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Groups:
This group receive Anahel medicine after surgery one quaderant of the upper jaw. An hour before the surgery and six hours after one dose. Intensity of the pain will be assessed with VAS and VRS at 2,4,6,8,10,12,24 and 48 hours after surgery.
Category
Treatment - Drugs
2
Description
Control Groups:
This group receive Ibuprofen medicine after surgery another quaderant of the upper jaw. An hour before the surgery and six hours after one dose. Intensity of the pain will be assessed with VAS and VRS at 2,4,6,8,10,12,24 and 48 hours after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Dentistry colleges of Tabriz
Full name of responsible person
Seyed Reza Kazemi
Street address
Dental colleges, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shariar Shahi
Street address
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental colleges of Tabriz
Full name of responsible person
Seyed Reza Kazemi
Position
Dental students
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Dental colleges
City
Tabriz
Postal code
Phone
+98 41 3335 7310
Fax
Email
Rezakazemi_Dent88@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental colleges of Tabriz
Full name of responsible person
Dr. Masoomeh Faramarzi
Position
Periodontology
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Dental colleges
City
Tabriz
Postal code
Phone
+98 41 3335 7310
Fax
Email
faramarzie@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MSc
Other areas of specialty/work
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)