Evaluation of color restoration on child lifestyle and comparison of clinical and radiographical of the composite restoration with stainless steel crown in restoration of multi-surface caries in primary molar teeth
Evaluation of color restoration on child lifestyle and comparison of clinical and radiographical of the composite restoration with stainless steel crown in restoration of multi-surface caries in primary molar teeth
Design
Clinical trial with two intervention groups, with factorial groups, double-blind, randomized on 44 patients
Settings and conduct
This study is performed in the specialized department of Kerman Dental School.A total of 44 teeth are selected in children who meet the entry and exit criteria.Children are randomly divided into the following two groups based on even and odd numbers: the first group: tooth restoration with ssc (control group) and the second group: tooth restoration with composite (study group).
At the end of the restoration session, a checklist to assess the parents and child's views on the appearance and color of the restoration is asked and completed immediately after viewing it.
The clinical and radiographic success rate of tooth restoration is evaluated at intervals of 3, 6 and 12 months, and in these 3 follow-up sessions, a checklist related to the views of the child and parents regarding the importance of tooth appearance and color and its impact on the child's daily life is completed. .
Participants/Inclusion and exclusion criteria
Inclusion criteria include: 1- Physical and mental health, 2- Age 4 to 6 years, 3- Frankl cooperation level 3 or 4, 4- No history of dental restoration treatment, 5- Having at least one deciduous tooth
Exclusion criteria included: 1- Lack of general health, 2- Lack of cooperation for treatment, 3- Having a history of deciduous molars restoration, 4- nonVital deciduous teeth, and 5- Tooth crowns were irreparable.
Intervention groups
Composite restoration and stainless steel crown restoration
Main outcome variables
Success rate of composite and ssc restoration; the effect of restoration color on the quality of life of the child
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200831048565N1
Registration date:2020-09-21, 1399/06/31
Registration timing:registered_while_recruiting
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Fateme Moslemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
fateme.moslemi1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of color restoration on child lifestyle and comparison of clinical and radiographical of the composite restoration with stainless steel crown in restoration of multi-surface caries in primary molar teeth
Public title
Evaluation of color restoration on child lifestyle and comparison of clinical and radiographical of the composite restoration with stainless steel crown in restoration of multi-surface caries in primary molar teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Physical and mental health
2- Age 4 to 6 years old
3- Frankl 3 or 4 level of cooperation
4- No history of dental restoration treatment
5- Having at least one deciduous molars with these conditions: a) According to radiography and signs and symptoms Clinical dental clinics. b) The teeth had caries of equal size and multilevel.
Exclusion criteria:
1- Lack of general health
2- Lack of cooperation for treatment
3- Having a history of restoration of deciduous molar teeth
4- Nonvital deciduous molar teeth
5- Tooth crowns were irreparable
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is simple randomization (coin tossing) and people are divided into two groups using coin tossing method. If after throwing it was on the coin line, the person is in the first group (tooth restoration with ssc) and if it was on the coin valve in the second group (tooth restoration with composite) and the coin is thrown until the specified sample volume is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The data were provided anonymously and in coded groups to the researcher, outcome assessor, data analyzer, and data monitoring committee.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of kerman university of medical sciences
The effect of color restoration on the quality of daily life of the child
Timepoint
Immediately after repair, 3 months, 6 months, 12 months
Method of measurement
Designed questionnaire
2
Description
Success rate of composite restoration and SSC
Timepoint
Immediately after repair, 3 months, 6 months, 12 months
Method of measurement
Clinical and radiographic examination
Secondary outcomes
empty
Intervention groups
1
Description
SSC restoration (control group): - Occlusion check - Separation of adjacent teeth with wooden wedge (enamel, Iran) - Proximal surfaces are cut with strile turbine bur (Tizkavan, Tehran, Iran) with rapid rotation and water spray. Contact with adjacent teeth was cut. - Cutting the cusps and occlusal surface was done using a strile turbine bur machine (Tizkavan, Tehran, Iran) with a high speed and water spray. A distance of 1 mm was created with the opposite tooth. - Any sharpness was removed using a strile turbine bur machine (Tizkavan, Tehran, Iran). Contour and crimp as needed. - SSC with glass ionomer (GC-Fuji l) was cemented.
Category
Treatment - Other
2
Description
Occlusion check - complete removal of caries and removal of unsupported enamel using strile turbine fissure bur (Tizkavan, Tehran, Iran) using water spray. - Application of a layer of optical glass ionomer cement with a thickness of 1 mm on the base Reinforced eugenol zinc oxide (Kemdent, England) was placed to prevent interference of eugenol with the resin polymerization reaction and then cured by a calibrated light curing device for 40 seconds.Adapting the brace to the tooth and placing the wedge (Mina, Iran) to accurately match the brace to the tooth and holding the brace in place - the cavity was etched for 37 seconds using 37% phosphoric acid gel (Kimia, Iran). The acid was then washed with water powder. The enamel part of the cavity was dried with air powder and the dentin part of the cavity was dried with a cotton ball. It was then cured by a calibrated light curing machine for 20 seconds. - Flow composite (VOCO-X-tra base, USA) was placed in layers with a maximum thickness of 4 mm at the bottom of the cavity and each layer for at least 40 seconds. It was cured using a calibrated light curing device.-A composite layer (VOCO-X-TRF FILL, USA) with a maximum thickness of 4 mm was placed on the occlusal surface and cured for at least 40 seconds using a calibrated light curing device.-Occlusion after removing the tail rubber with The use of an articulation paper was checked and, if necessary, adjusted with a polishing bur (American Sharpener).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
kerman medical science univercity
Full name of responsible person
Raziyeh Shojaeipour
Street address
Dental school, Shafa Ave, Jomhoori Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
fateme.moslemi1991@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Raziyeh Shojaeipour
Street address
Dental school, Shafa Ave, Jomhoori Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
fateme.moslemi1991@gmail.com
Grant name
Oral and Dental Diseases Research Center, Kerman University of Medical Science, Kerman, Iran
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Raziyeh Shojaeipour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school, Shafa Ave, Jomhoori Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
fateme.moslemi1991@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Raziyeh Shojaeipoor
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school, Shafa Ave, Jomhoori Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
003432119021
Email
fateme.moslemi1991@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Raziyeh Shojaeipoor
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school, Shafa Ave, Jomhoori Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
003432119021
Email
fateme.moslemi1991@gmail.com
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