This study has been evaluated the effect of Punica L. lozenge in controlling gag reflex during dental treatment. This study was a Randomized double blind controlled trial with convenient sampling. Inclusion criteria: The basic requirements for admission were determined good cooperation; Fill a standard consent form (The patients who assigned criteria of the Helsinki Declaration entered in our study), Exclusion criteria: Patients with any central; peripheral nervous system lesions or oral lesions were excluded.Samples were selected from patients who referred to Radiology Department of Dental School of Isfahan University of Medical Sciences. 84 patients entered in each group of intervention (with Punica L. Extracts) or control (with placebo) by randomization procedure. Gag reflex was evaluated by abslung stimulation before and after using placebo and lozenge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108126578N2
Registration date:2011-09-22, 1390/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Elham Shadmehr
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 0955
Email address
elham.shadmehr@gmail.com
Recruitment status
Recruitment complete
Funding source
Research Department of Isfahan University of Medical Sciences
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2008-03-19, 1386/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Punica L. lozenge on gag reflex in dental patients
Public title
Effect of Punica L. lozenge on gag reflex in dental patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: good cooperation; Fill and assigned standard consent form of criteria of the Helsinki Declaration, Exclusion criteria: Patients with any central nervous system lesions; any peripheral nervous system lesions; any oral lesions.
Age
From 10 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Department of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2008-08-21, 1387/05/31
Ethics committee reference number
387082
Health conditions studied
1
Description of health condition studied
Gag Reflex
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Degree of Gag Reflex sevierity
Timepoint
5 min after usage of placebo or lozenge
Method of measurement
Before and after intervention, gag reflex was evaluated by stimulation of soft palate and pharyngeal tonsils with Abslang.
Secondary outcomes
1
Description
Mouth anesthesia
Timepoint
5min
Method of measurement
stimulation of soft palate and tonsils
Intervention groups
1
Description
After determining the sevierity of Gag reflex,encoded lozenge (Punica L. lozange) was given to each patient. This was done by a third person. After five minutes, the Gag reflex severity in the areas of soft palate and pharyngeal tonsils were evaluated again by the same examiner and the final results were recorded.Finally,the case group was distincted by the code number from the control group.
Category
Placebo
2
Description
After determining the sevierity of Gag reflex,encoded lozenge (plaecebo lozang) was given to each patient. This was done by a third person . After five minutes, the Gag reflex severity in the areas of soft palate and pharyngeal tonsils were evaluated again by the same examiner and the final results were recorded.Finally,the control group was distincted by the code number from the case group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences, Radiology Department
Full name of responsible person
Dr. Ehsan Hekmatian
Street address
Isfahan University of Medical Sciences, Dental School
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Isfahan University of Medical Sciences
Full name of responsible person
Tavangar Mr.
Street address
Dental School, Isfahan University of Medical Sciences.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Hekmatian
Position
Assistant professor of maxillofacial radiology, Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
87986546
Phone
+98 913 327 2159
Fax
+98 913 327 2159
Email
hekmatian@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Hekmatian
Position
Assistant professor of maxillofacial radiology, Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 913 327 2159
Fax
+98 913 327 2159
Email
hekmatian@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Pharmacy , Isfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Asghari
Position
Professor of pharmacognosy
Other areas of specialty/work
Street address
School of pharmacy , Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)