Investigating the effects of mucosal adhesives containing resveratrol on gingival inflammation indexes in patients undergoing fixed orthodontic treatment
Investigating the effects of mucosal adhesives containing resveratrol on gingival inflammation indexes in patients undergoing fixed orthodontic treatment
Design
This study is a blind clinical trial.The study population included all patients referring to the School of Dentistry in Kermanshah city.60 eligible patients will be selected conveniently and randomly assigned to three intervention groups.
Settings and conduct
This study, which will be carried out at Kermanshah city Dental School, is a blinded one, so that the participants do not know what medicine they will receive. At the beginning of the study,The plaque status , gingival and periodontal indexes are recorded in a checklist in all three groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of severe periodontal disease or periodontal surgery
Exclusion criteria: severe gingival bleeding
Intervention groups
The first intervention group received an orthodontic device without using a mucosal adhesive containing resveratrol
The second intervention group will receive an orthodontic device with using a mucous adhesive containing 1% resveratrol and for 14 nights will use the mucous adhesive routinely after the brushing, every night.
The third intervention group will receive an orthodontic device with using a mucous adhesive containing 2% resveratrol and for 14 nights will use the mucous adhesive routinely after the brushing, every night.
Main outcome variables
Plaque status ; Gingival bleeding; Periodontal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N91
Registration date:2018-05-19, 1397/02/29
Registration timing:prospective
Last update:2018-05-19, 1397/02/29
Update count:0
Registration date
2018-05-19, 1397/02/29
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-26, 1397/03/05
Expected recruitment end date
2018-07-27, 1397/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of mucosal adhesives containing resveratrol on gingival inflammation indexes in patients undergoing fixed orthodontic treatment
Public title
Investigating the effects of mucosal adhesives on gingival inflammation indexes in patients undergoing fixed orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of severe periodontal disease or periodontal surgery
The need for fixed orthodontic treatment
Do not use drugs or mouthwashes
Not having a systematic illness
Age between 10 to 18 years
Exclusion criteria:
Severe gingival bleeding
Age
From 10 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
ir.kums.rec.1396.700
Health conditions studied
1
Description of health condition studied
Gingival inflammation
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
Plaque status
Timepoint
The beginning and end of the study
Method of measurement
Based on the gingival index (GI)
2
Description
Bleeding of gingival
Timepoint
The beginning and end of the study
Method of measurement
Based on the gingival bleeding index (GBI)
3
Description
Periodontal
Timepoint
The beginning and end of the study
Method of measurement
Using periodontal probes
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group received an orthodontic device without using a mucosal adhesive containing resveratrol
Category
Treatment - Other
2
Description
The second intervention group will receive an orthodontic device with using a mucous adhesive containing 1% resveratrol and for 14 nights will use the mucous adhesive routinely after the brushing, every night, .
Category
Treatment - Other
3
Description
The third intervention group will receive an orthodontic device with using a mucous adhesive containing 2% resveratrol and for 14 nights will use the mucous adhesive routinely after the brushing, every night,
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Fatemeh Ghorbani
Street address
Shariati Avenue - above Shura Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
f_Ghorbani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Ghorbani
Position
MSc Biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Shariati Avenue - above Shura Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 37222400
Email
F_ghorbani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amin Golshah
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shariati Avenue - above Shura Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
amin.golshah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Ghorbani
Position
MSc Biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Shariati Avenue - above Shura Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Email
f_Ghorbani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail