Aim of study: determine and compare the mean of tooth sensitivity after in-office bleaching with capsaicin and placebo at different times
Study design : randomized,single blind,control with placebo,crossover
methods and materials :
a)study population
inclusion criteria: have 6 anterior maxillae teeth without restoration on labial surface
exclusion criteria: pregnant or lactating , tooth sensitivity history,expose dentine into oral cavity
each group sample size:30 total sample size:60
b)intervention:
participants received placebo before bleaching and mark their sensitivity in VAS forms. 2weeks after they received capsaicin 0/25% before bleaching.
c) intervention time:
both group received placebo and drug 1 hour before treatment and two other capsules were administered every 8 hours during 24 hours.
d) primary outcome:
tooth sensitivity
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122825729N1
Registration date:2016-07-30, 1395/05/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Maryam Montazeri Shahtouri
Name of organization / entity
dentistry school
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2836
Email address
samimi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
done with personal expense
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of systemic capsaicin on the prevention of tooth sensitivity after in-office bleaching
Public title
Drug effect on tooth sensitivity after bleaching
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) at least 18 yrs old 2) good oral hygiene 3) 6 anterior maxillary teeth without restorations on labial surface 4) exist all 6 anterior maxillary teeth 5) no smoking 6) no recession 7) central incisor with A3 or lighter according (Vita shade guide,Vita Zahnfabrik ,Bad Sackingen,Germany)
Exclusion criteria :
1) who have a history of nay medical diseases that may interfere with the study 2)smoking in the past 30 days 3) have oral lesion 4) pregnant or lactating women 5) calculus or sever tooth discoloration 6) tooth sensitivity 7) expose dentine into oral cavity 8) who use desensitizer products 9) having sever tooth sensitivity after bleaching
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research chancellery of Isfahan university of medical sciences
Street address
Hezar jerib St, Isfahan university of medical sciences
City
Isfahan
Postal code
Approval date
2016-06-06, 1395/03/17
Ethics committee reference number
ir.mui.rec.1395.3.193
Health conditions studied
1
Description of health condition studied
tooth discolaration
ICD-10 code
K03.6
ICD-10 code description
staining,tooth,teeth (hard tissues) (extrinsic
Primary outcomes
1
Description
tooth sensitivity
Timepoint
1 h before operation and taking capsules,just after operation,1h and 24h after operation
Method of measurement
VAS form
Secondary outcomes
empty
Intervention groups
1
Description
(Control group:placebo,taking similar to intervention group, every 8 hours (three times a day).
Category
Placebo
2
Description
Intervention group:Capsaicin,capsule 0/25%(50 mg),oral,take every 8 hours (three times a day).( capsules made in Isfahan pharmacology school and capsaicin powder is taken from Amin Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental School
Full name of responsible person
Maryam Montazeri Shahtouri, Post-graduate student of operative dentistry
Street address
Operative dentistry section of Isfahan Dental School
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
personal fund
Full name of responsible person
Maryam Montazeri Shahtouri
Street address
Operative dentistry section,Isfahan dental school
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
personal fund
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 Dental School
Full name of responsible person
Maryam Montazeri Shahtouri
Position
Post-graduate student of operative dentistry
Other areas of specialty/work
Street address
Hear jerib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 316692588
Fax
Email
maryammontazeri.sh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
school of dentistry
Full name of responsible person
pouran samimi dehkordi
Position
associated proffessor
Other areas of specialty/work
Street address
Hezar jerib St, Isfahan university of medical sciences
City
Isfahan
Postal code
Phone
+98 316692588
Fax
Email
samimi@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan dental school
Full name of responsible person
Maryam Montazeri Shahtouri
Position
post graduate student of operative dentistry
Other areas of specialty/work
Street address
hezar jerib st, Isfahan university of medical sciences
City
Isfahan
Postal code
Phone
+98 316692588
Fax
Email
maryammontazeri.sh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)