Comparative clinical performance evaluation of diffrent materials in restoration of none carious cervical lesions in patients reffer to restorative department of esfahan dentistry university
Objective of study is: The comparision between clinical performance index of different materials in restoration of None carious cervical lesions.
Design:Not blinded randomized clinical trial
Participants and major eligibility criteria: 25 patients with none carious cervical lesions, the patients must have 5 lesions with the depth of 2 mm or more
Major exclusion criteria: Carious lesions
Setting and conduct: The teeth will clean with rubber cup and pumice before restoring of the teeth.The shade selection done and no preparation and bevel is required. Isolation with cotton rolls and suction will be done and then the teeth randomly will devide into 5 groups.
Intervention: In the first group after etching and bonding(Clearfill SE Bond) procedure,the cavity will restore only with Point4 composite.
In the second group after etching and bonding (Clearfill SE Bond)cavity will restore only with Gradia flow composite.
In the third group cavity will restore with Resin modified glass ionomer Fuji II LC.
In the fourth group after use of Dentin conditioner(10% Polyacrilic acid) Conventional glass ionomer(EQUIA FIL), will use to restore cavity.
In fifth group at first Vitrebond will use as an intermediate layer and after curing, Point 4 composite will use to cover it(Sandwich technique).
Then all of the groups will finish with ultrafine bur and will polish with Sof-Lex Pop On discs. The teeth will assessed with Modified United States Public Health Service criteria(USPHS) in terms of Retention(main outcome variables) , Marginal integrity, Marginal discoloration, Recurrent caries, Surface texture and Anatomic form after 6 months and 12 months,finally the results will evaluate with statistical analysis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121925607N1
Registration date:2016-04-10, 1395/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-10, 1395/01/22
Registrant information
Name
Sepideh Kazemizadeh
Name of organization / entity
Esfahan dentistry school/Esfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 9492
Email address
f_shirani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Esfahan university of medical science
Expected recruitment start date
2016-03-15, 1394/12/25
Expected recruitment end date
2016-04-29, 1395/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative clinical performance evaluation of diffrent materials in restoration of none carious cervical lesions in patients reffer to restorative department of esfahan dentistry university
Public title
The effect of different restorative material in the cervical of teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: None carious lesions; depth of lesions 2 mm or more; enamel and dentin involvement without pulpal involvement and mobility of tooth; lesions in buccal surface
Exclusion criteria: Carious lesions; patients with poor oral hyegin; history of bruxism and xerostomia; complicated systemic conditions; sever choronic periodontitis and sever attrition(more than 50% loss of occlusal and incisal )
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
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 committe of Esfahan university of medical science
Street address
Esfahan university of medical science, Hezarjarib avenue,Esfahan
City
Esfahan
Postal code
8174673461
Approval date
2015-04-30, 1394/02/10
Ethics committee reference number
ir.mui.rec.1394.3.857
Health conditions studied
1
Description of health condition studied
None carious cervical lesions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Retention
Timepoint
6 and 12 Months after intervention
Method of measurement
USPHS Chart
Secondary outcomes
1
Description
Marginal integrity
Timepoint
6 and 12 Months after intervention
Method of measurement
USPHS Chart
2
Description
Marginal Discoloration
Timepoint
6 and 12 Months after intervention
Method of measurement
USPHS Chart
3
Description
Recurrent Caries
Timepoint
6 and 12 Months after intervention
Method of measurement
USPHS Chart
4
Description
Surface Texture
Timepoint
6 and 12 Months after intervention
Method of measurement
USPHS Chart
5
Description
Anatomic Form
Timepoint
6 and 12 Months after intervention
Method of measurement
USPHS Chart
Intervention groups
1
Description
First group:Point 4 Composite
Category
Treatment - Drugs
2
Description
Second group:Gradia flow Composite
Category
Treatment - Drugs
3
Description
Third group:Fuji II LC
Category
Treatment - Drugs
4
Description
Forth group:Equia Fil
Category
Treatment - Drugs
5
Description
Fifth group:Vitre bond+Point 4 Composite
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Professional operative department of Esfahan dentistry school
Full name of responsible person
Dr Farzaneh Shirani(Professor of operative dentistry)
Street address
Esfahan dentistry school, Esfahan university of medical science, Hezarjarib avenue, Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Esfahan university of medical science
Full name of responsible person
Dr mehdi nematbakhsh( Vice chancellor for research of Esfahan university of medical science)
Street address
Vice chancellor, Esfahan university of medical science,Hezarjarib avenue, Esfahan
City
Esfahan
Grant name
Grant code / Reference number
394857
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Esfahan university of medical science
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
Esfahan Dentistry School
Full name of responsible person
Doctor Sepideh Kazemizadeh
Position
Dentist/postgraduate of operative dentistry
Other areas of specialty/work
Street address
Esfahan dentistry school, Esfahan University of Medical Sciences, Hezarjarib avenue, Esfahan