evaluation of effect of carbamide peroxide 16% on sulcus bleeding index/Plaque index/Gingival index
Design
30 patients will be selected for clinical trial according to the criteria for inclusion in and exclusion.gingival health in after bleaching and before bleaching compared.
without control group
study group: consider of gingival health condition before bleachingand reconsider of gingival health condition after bleaching on selfsame patient
all patient inclusion in study reconsider after treatment and withput blinding and randomised.
phase 2-single type of intervention group
Settings and conduct
30 patients referring to the Department of Operative Dentistry, Zahedan Faculty of Dentistry-
home special tray for one persone is composing patient’s special tray is tested . The tube gel carbamaid proxide 16% is given to each patient with its applying instructions. The time to apply is 4 hours a day in tray until 14 days. The patient refers back after 14 days . In this stage health indices of the gum including bleeding index sulcus and gingival index and plaque index are measured
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women aged 18-30 years
Without any anterior treatment
People without tooth decay
People with no Gingivitis and periodontal diseases
People without tooth root spreading
People without cervical lesions (Non Caries Cervical Lesions)
Non-pregnant and non-lactating women
Lack of calculus
Non-smokers
Non changing the colors caused by fluorosis and tetracycline
Exit criteria:
Patients who have not been studied or have not been able to continue treatment.
Intervention groups
bleching with carbamide peroxide 16% gel
Main outcome variables
plaque index
sulcus bleeding index
gingival index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170210032484N3
Registration date:2018-05-11, 1397/02/21
Registration timing:retrospective
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
Somayeh Somaye
Name of organization / entity
Dentistary
Country
Iran (Islamic Republic of)
Phone
+98 915 341 6206
Email address
somayehtabatabaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2018-04-03, 1397/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of used dental bleaching carbamide peroxide 16% gel on gingival health in 18 to 30 years
Public title
Assessing the effect of used home bleaching on gingival health in 18 to 30 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:Non-smokers
Women aged 18-30 years
With natural anterior teeth with A2, B2, C2, D2 colors and darker (Vitapan Classic Shade)
Minimum of 24 teeth
Suitable oral hygiene
Patient Satisfaction
Exclusion criteria:
People tooth decay
People with Gingivitis and periodontal diseases
People tooth root spreading
People cervical lesions NCCL (Non Caries Cervical Lesions)
People who do have Ortho treatment
pregnant and lactating women
Lack of calculus
People bleach treatment history in the past
Individuals changing the colors caused by fluorosis and tetracycline
any anterior restoration
Age
From 18 years old to 30 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
West Azadegan , Khoramshahr Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR. ZAUMS. REC.1396.372
Health conditions studied
1
Description of health condition studied
Effect of Carbamide peroxide on Gingival health
ICD-10 code
T49.7
ICD-10 code description
Poisoning by, adverse effect of and underdosing of dental drugs, topically applied
Primary outcomes
1
Description
Gingival index
Timepoint
1to 14 days after start bleaching
Method of measurement
Clinical examination of gingival health index
2
Description
Sulcus bleeding index
Timepoint
1to 14 days after start bleaching
Method of measurement
Probing
3
Description
Plaque index
Timepoint
1to 14 days after start bleaching
Method of measurement
Disclosing agent
Secondary outcomes
empty
Intervention groups
1
Description
patients ,Before starting treatmen:, the required explanations about stages of treatment will be provided to patients and written consent will be obtained The dates of the attendance of the participants in the various meetings will be given in writing to them.In order to improve the oral health condition, a soft toothbrush and identical toothpastes and floss will be given to each patient. The same technique of brushing (Bass technique) and the same way of flossing will be trained (3 times a day for brushing teeth at correct times, noon and night, and floss once a night); and They should refrain from using other oral hygiene products.Patients will be required to refrain from eating any colorful drinks, such as tea, coffee, Nescafé, and wine during the bleaching process.At this stage, gingival health indicators including sulcus bleeding index and gingival index and plaque index will be measured For each patient a prophylaxis is performed with oil-free prophylactic paste in order to omit the foreign pigments (by the student). Each patient will receive Alginate templates (by the student) and after confirming the template's correctness by the supervisor, chalk cast is immediately prepared after molding (by the student). The patient is notified about the next appointment.Physical surfaces of teeth is excluded in gypsum casts with a distance of 0.5 mm from gingival margin to ensisal block (it is done by the library technician).In next appointment, patient’s special tray is tested in his mouth and checked in relation to accordance with the teeth and gum margin. If not complied, it is made again. Maintenance training of the tray is presented during treatment. Bleaching tube jell is carbamaid proxide 16% (whiteness perfect (FGM Dental- products , Joinville, Sc, brazil).The tube jell is given to each patient the same day with its applying. instructions. The time to apply is 4 hours a day in tray until 14 days. The instructions are presented both orally and in writing. all of this patients after treatment :The patient refers back after 14 days and SBI and PI and GI measured again.and compared with data of before treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Restorative Dentistry Department, Dental College of Zahedan
Full name of responsible person
Doctor Tabtabayie Somaye
Street address
Azadegan Str
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Phone
+98 54 1341 6708
Email
mjasgharzadehfirstjarobahs@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Doctor Rafighdoost Hooshang
Street address
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3342 4852
Email
mohamadjavadasgharzadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohammad javad Asgharzadeh
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Phone
+98 54 1341 6708
Email
mjasgharzadehfirstjarobahs@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Doctor Tabatabayie Somaye
Position
Dental College of Zahedan University of Medical Sciences, Azadegan St. Zahedan, Iran
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan Str
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98176-43463
Phone
+98 54 1341 6708
Email
somayehtabatabaei@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Doctor Tabatabayie Somaye
Position
Assistant Professor of Restorative Dentistry Department, Dental College of Zahedan University of Med
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan Str
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54134116708
Email
somayehtabatabaei@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available