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Clinical evaluation of a Low-shrinkage Methacrylate-Based composite compared with a packable composite in posterior restorations

Protocol summary

Summary
The aim of this study is to evaluate the clinical performance of two composites(P60,Kalore) in posterior restorations . In this randomized clinical trial study, fifty restorations is placed in 25 patients. Each patient receives two class I or II restorations,Half of cavity preparations were randomly restored with P60 and the other half with Kalore GC).Patients with poor oral hygiene, parafunctional habits , a known allergy to the substances used in this study, and periodontal diseases were excluded.informed consent was obtained from each patient .The restorations are evaluated by two independent examiners after one week (baseline), six months and one year according to the modified United States Public Health Service (USPHS) criteria. The evaluated characteristics are: colour match, marginal adaptation, anatomical form, retention, surface texture, post-operative sensitivity, marginal staining and secondary caries. For each of the criteria, a score of Alpha represented the ideal clinical situation, Bravo was clinically acceptable, and Charlie indicated a clinically unacceptable situation. Two examiners, analyst and patients were unaware which composite is used

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070528804N1
Registration date: 2016-07-17, 1395/04/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-17, 1395/04/27
Registrant information
Name
Razieh Hosseinifar
Name of organization / entity
Dental School, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
r.hosseinifar@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2015-07-05, 1394/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of a Low-shrinkage Methacrylate-Based composite compared with a packable composite in posterior restorations
Public title
evaluation of tooth colored restoration materials
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: over 18 years old, stable dentition without periodontal disease, 2 restorations required, vital tooth ; exclusion criteria: poor oral hygiene, parafunctional habits, a known allergy to the substances used in this study, history of existing tooth sensitivity, pregnancy or breast-feeding, chronic use of anti-inflammatory, analgesic, and psychotropic drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the patients, the researchers and the analyst were unaware of the type of composite, therefore it considers as three blind. Randomization: In order to fill the first cavity, regardless of the type of it (class I or II), between the two composite draw was performed and selected composite was used. Thus the second hole was filled with second composite.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman Univesity of Medical Sciences
Street address
begining of Haftbagh Alavi highway
City
Kerman
Postal code
Approval date
2014-01-05, 1392/10/15
Ethics committee reference number
ک.ا/480/92

Health conditions studied

1

Description of health condition studied
clinical performance of tooth colored restoration materials
ICD-10 code
K02.1
ICD-10 code description
dentin caries

Primary outcomes

1

Description
retention
Timepoint
one week, 6 months and one year
Method of measurement
visual examination

Secondary outcomes

1

Description
color match
Timepoint
one week, 6 months and one year
Method of measurement
visual examination and photography

2

Description
marginal adaptation
Timepoint
one week, 6 months and one year
Method of measurement
visual and tactile examination with explorer

3

Description
surface roughness
Timepoint
one week, 6 months and one year
Method of measurement
visual and tactile examination with explorer

4

Description
marginal staining
Timepoint
one week, 6 months and one year
Method of measurement
visual examination and photography

5

Description
sensitivity
Timepoint
one week, 6 months and one year
Method of measurement
asking the patient

6

Description
secondary caries
Timepoint
one week, 6 months and one year
Method of measurement
visual and tactile examination with explorer and radiograghy

7

Description
anatomical form
Timepoint
one week, 6 months and one year
Method of measurement
visual examination

Intervention groups

1

Description
Teeth restorating with tooth colored material Filtek P60 (3M, ESPE, St Paul, USA)
Category
Treatment - Other

2

Description
Teeth restorating with tooth colored material Kalore GC (GC Corporation, Tokyo, Japan)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman Dental School
Full name of responsible person
Razieh Hosseinifar
Street address
end of Shafa Ave., Kerman Dental School
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
dr Abbas Pardakhty
Street address
begining of Ebn-e-Sina Ave., Tahmasbabad four-way
City
Kerman
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, Kerman 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Dentistry, Kerman University of Medical Sciences
Full name of responsible person
Hassan Mollahassani
Position
postgraduate
Other areas of specialty/work
Street address
end of Shafa Ave., Kerman Dental School
City
Kerman
Postal code
Phone
+98 34 3211 9022
Fax
Email
h_mollahasani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Dentistry, Kerman University of Medical Sciences
Full name of responsible person
Razieh Hosseinifar
Position
assisstant professor
Other areas of specialty/work
Street address
end of Shafa Ave., Kerman Dental School
City
Kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
r.hosseinifar@kmu.ac.ir; r_hoseiniffar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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