One hundred eighty two patients are recruited from those needing scaling and root planing referred to the Guilan University of Medical Sciences, Dental Faculty, Department of Periodontology. Following initial examination and obtaining informed consent, participants are divided into two groups using a randomized block design. Group 1 receives one capsule containing starch as a placebo half an hour before the procedure and they are told that the drug is a potent pain killer, while the other group receives no additional treatment rather than scaling and root planing. For each patient demographic characteristics and periodontal parameters are recorded before treatment and they are asked to complete a modified dental anxiety index questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212041081N6
Registration date:2013-03-03, 1391/12/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-03, 1391/12/13
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
ِِDeputy of Research, Guilan University of Medical Sciences
Expected recruitment start date
2012-12-20, 1391/09/30
Expected recruitment end date
2013-07-20, 1392/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of placebo effect for pain control during scaling and root planning
Public title
Pain control induced by placebo effect during scaling and root planing
Purpose
Treatment
Inclusion/Exclusion criteria
Volunteers seeking scaling and root planing and have either gingivitis or periodontitis are selected. Inclusion criteria: Being in a good general health; having at least 3 standing teeth in each sextant of dentition; not consuming any drugs such as anti-depressants; corticosteroids; ant-coagulants; NSAIDs; anti-inflammatory; and etc.
Patients needing anti-biotic prophylaxis, as well as pregnant or lactating women are excluded from the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
182
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Visual analogue Scale and a five -point verbal rating Scale are used for pain measurement. To eliminate effects of anxiety on pain reported by the patients, a Modified Dental anxiety Scale is used.In case of severe and non-tolerable pain during procedure, local anesthesia by infiltration injection is performed as a rescue analgesic medication.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
guilan university of medical sciences
Street address
Namjoo BLV, Mellat Str. Guilan University of Medical Sciences Building
City
rasht
Postal code
4188794755
Approval date
2013-02-09, 1391/11/21
Ethics committee reference number
3910396405
Health conditions studied
1
Description of health condition studied
pain during scaling and root planing
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
2
Description of health condition studied
Pain during scaling and root planing
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
pain severity
Timepoint
During intervention
Method of measurement
visual analogue scale, Five point verbal rating scale
Secondary outcomes
1
Description
Treatment of gingivitis and/or periodontitis
Timepoint
At the time of admission, and four weeks after scaling
Method of measurement
Probing pocket depth
Intervention groups
1
Description
Placebo capsule, one single dose, 0.5 to 1 hour before scaling and root planing
Category
Placebo
2
Description
Control group, no medication before scaling and root planing
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry Guilan University of Medical Sciences
Full name of responsible person
Golpar Radafshar
Street address
No 11, 114th Street, Golsar Blv.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Gillan University of Medical Sciences
Full name of responsible person
Mrs.Susan Komaie
Street address
Research and Technology Building,Namjoo Street, Gaz Square
City
rasht
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, Gillan 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
Oral and Maxillofacial Developmenatal Disease Research Center
Full name of responsible person
Nastaran Mirfarhadi
Position
MS Nursing education
Other areas of specialty/work
Street address
Guilan University of Medical Sciences Complex Buildings, Faculty of Dentistry, Saravan Free way, Lakan Road
City
Rasht
Postal code
Phone
+98 13 1326 3616
Fax
+98 13 1326 3616
Email
mirfarhadi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences, Faculty of Dentistry, Department of Periodontology
Full name of responsible person
Golpar Radafshar
Position
Head of Oral and Maxillo-facial Developmental Disease Research Center/ Associate Professor of Period
Other areas of specialty/work
Street address
Gillan University of Medical Sciences complex Buildings, Faculty of Dentistry,Saravan Free way, Lakan Road
City
Rasht
Postal code
Phone
+98 13 1326 3616
Fax
+98 13 1326 3616
Email
golishad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Periodontology,Faculty of Dentistry,Guilan University of Medial Sciences
Full name of responsible person
Golpar Radafshar
Position
Head of Oral and Maxillo-facial Developmental Disease Research Center/ Associate Professor of Period
Other areas of specialty/work
Street address
Guilan University of Medical Sciences Complex Buildings, Saravan Free way, Lakan road
City
Rasht
Postal code
Phone
+98 13 1326 3616
Fax
+98 13 1326 3616
Email
golishad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)