Objectives: To determine the effect of Benzydamine hydrochloride mouthwash and ibuprofen to reduce pain after crown lengthening surgery and determine the average pain scores between the two groups.
Design: Ethics Committee approval (number 63 942) and written consent from patients will be taken. Surgery by a two-year surgical resident will be done. surgical techniques will be the same for all patients. Operative pain in the first 24 hours after surgery were recorded.
Setting and conduct: patients divided into two equal groups. The first group is requested to rinse Benzydamine hydrochloride mouthwash 0.15 % every 3 hours for 30 seconds and the second group will be asked to take a ibuprofen 400 mg pill every 6 hours.
Major Inclusion and Exclusion criteria: Inclusion criteria include Contact periodontal status; require surgery on the posterior teeth; not taking any painkillers or anti-inflammatory during the last 6 months; lack of systemic problems; no contraindications for ibuprofen or benzydamine and exclusion criteria include lack of desire to participate in the plan; effective pain medication during the past 6 months, the risk of systemic problems affecting the periodontal tissues, ibuprofen or Benzydamine is contraindicated.
Intervention: Intervention group: rinse with benzydamine hydrochloride mouthwash 0.15% (the pharmaceutical company "Exir" Boroujerd) at a rate of once every 3 hours 15 ml for 30 seconds in mouth. Control group: consume ibuprofen 400 mg tablets every 6 hours (the pharmaceutical company "Hakim").
The main outcome variables: age, sex, VAS
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012312847N2
Registration date:2016-03-02, 1394/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-02, 1394/12/12
Registrant information
Name
Arezoo Khabazian
Name of organization / entity
Shahid Sadoghi University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 8852
Email address
arezookhabazian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadooghi University Of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Benzydamine HCl 0.15% mouthwash and Ibuprofen effect on pain relief after crown lengthening, a clinical trial
Public title
Comparison of Benzydamine HCl 0.15% mouthwash and Ibuprofen effect on pain relief after crown lengthening, a clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Periodontal health establishment؛ require crown lengthening surgery in the posterior teeth؛ avoiding the use of any painkiller or anti-inflammatory or Counter during the last 6 months؛ lack of systemic problems؛ lack of contraindications of ibuprofen or Benzydamine hydrochloride mouthwash. Benzydamine hydrochloride contraindications include hypersensitivity to the drug or formulation components؛ children under 12 years of age؛ past medical history and feed intake. Warning of eye contact with the drug. The classification used in pregnancy؛ is in category C. It should not be administered to a patient more than 7 days؛ and in case of allergies؛ medication should be discontinued. Information on medication safety in nursing mothers. Contraindications Ibuprofen include third trimester of pregnancy (the drugs X)؛ such as anaphylaxis or Angioedema history of severe allergic reaction caused by aspirin or other non steroidal anti-inflammatory drugs or nose polyp with spasticity due to an inflammatory disease or ulcerative the upper or lower gastrointestinal tract ؛ hemophilia and other blood disorders؛ including disorders of hemostasis؛ or platelets؛ kidney disorders ؛ stomatitis and elderly patients and patients the risk of gastrointestinal bleeding and ulcers in them is high. Concomitant use of ibuprofen with inhibitors of angiotensin converting enzyme (ACE)؛ one of the quinolone antibacterial agents؛ hypoglycemic sulfonylurea drugs؛ cyclosporine؛ lithium and methotrexate may؛ anticoagulants or thrombolytic؛ triamterene؛ valproic acid؛ aspirin and performance they interference is increasing or decreasing.
Exclusion criteria: Unwillingness to participate in the plan؛ effective pain medications (analgesics or anti-inflammatory drug or drug) during the last 6 months؛ the risk of systemic problems affecting the periodontal tissues (diabetes؛ hypertension and heart disease؛ vascular)؛ ibuprofen is contraindicated or mouthwash Benzydamine hydrochloride.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
1
Registry name
000
Secondary trial Id
000
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadooghi University Of Medical Sciences
Street address
Dahe Fajr Blv, Yazd
City
Yazd
Postal code
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.SSU.REC.1394.30
Health conditions studied
1
Description of health condition studied
crown lengthing surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
24 hours after intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
stingling & numbness
Timepoint
24 hours after intervention
Method of measurement
asking from patient
Intervention groups
1
Description
Intervention group: rinse with benzydamine hydrochloride mouthwash 0.15% (the pharmaceutical company "Exir" Boroujerd) at a rate of once every 3 hours 15 ml for 30 seconds in mouth.
Category
Treatment - Drugs
2
Description
Control group: consume ibuprofen 400 mg tablets every 6 hours (the pharmaceutical company "Hakim").
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadooghi University Of Medical Sciences
Full name of responsible person
Arezoo Khabazian
Street address
Dahe Fajr Blv, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Sadooghi University Of Medical Sciences
Full name of responsible person
Dr Amir Hooshang Mehrparvar
Street address
Shahid Bahonar Square, Yazd
City
Yazd
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 of Shahid Sadooghi University Of Medical Sciences