In this in-vivo study we aim to use this cement for luting SSCs and compare clinical survival of the crowns cemented with novel Protooth cement and glass ionomer cement.
Design
This study is designed as a split-mouth and the teeth will be intervened bilaterally in one person (SSC will be cemented in the right quadrant teeth with glass ionomer cement and in the left quadrant teeth with the new protooth cement, regardless of the condition of the teeth and the degree of destruction). In this study, the groups are parallel and the sample size of 50 teeth will be randomly divided into two groups of 25 teeth. This study will be double blind.
Settings and conduct
In this study, all teeth will be restored by a post-graduate student of pediatric dentistry. Teeth with extensive proximal and/or occlusal caries and root-treated teeth will be selected. Crowns will be evaluated 6 months after cementation. In the follow-up session, clinical examination and intraoral camera observation of each crown will be done independently by two pediatric dental specialists, without knowing the type of cement.
Participants/Inclusion and exclusion criteria
Children with extensive caries in primary molars requiring restoration with stainless steel crowns (SSC).
Intervention groups
This study is designed as a split-mouth and the teeth will be intervened bilaterally in one person (SSC will be cemented in the right quadrant teeth with glass ionomer cement and in the left quadrant teeth with the new protooth cement, regardless of the condition of the teeth and the degree of destruction).
Main outcome variables
Check of SSC's mobility Recording the clinical views of SSCs using an intraoral camera and examining occlusal wear and perforation of SSC Investigating the Crown's loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161227031608N3
Registration date:2023-10-30, 1402/08/08
Registration timing:prospective
Last update:2023-10-30, 1402/08/08
Update count:0
Registration date
2023-10-30, 1402/08/08
Registrant information
Name
Ali Vafaei
Name of organization / entity
Tabriz medical sciences university
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0310
Email address
drvafaeia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical durability of stainless steel crowns cemented with glass ionomer cement and Protooth silicate cement in primary molar teeth
Public title
Evaluation of clinical durability of stainless steel crowns cemented with glass ionomer cement and Protooth silicate cement in primary molar teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 2 to 12 years old
Children with extensive caries in primary molars requiring restoration with stainless steel crowns (SSC).
Exclusion criteria:
Children who have less than two decayed teeth in their oral cavity
Age
From 2 years old to 12 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
In each person, SSC will be cemented in the teeth involved in the right quadrant with glass ionomer cement and in the teeth involved in the left quadrant with Protooh cement.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the specialists who are responsible for checking the crowns in certain time intervals will not know about the type of cement, and the reviewers will only collect information about the durability of the crown.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht st., Tabriz University of Medical Sciences, Faculty of Dentistry, Pediatric dentistry department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-02-19, 1401/11/30
Ethics committee reference number
IR.TBZMED.REC.1401.1043
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
SSC mobility (yes/no)
Timepoint
6 months
Method of measurement
Spoon excavator
2
Description
SSC wear (yes/no)
Timepoint
6 months
Method of measurement
Clinical examination
3
Description
SSC perforation (yes/no)
Timepoint
6 months
Method of measurement
Clinical examination
4
Description
loss of SSC (Yes/No)
Timepoint
6 months
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: SSC cemented with Protooth (Ultrafast Protooth cement, Dentosolve, Aarhus, Denmark). The material is mixed with the right consistency and two-thirds of the SSC is filled with cement. After drying the tooth under suitable isolation conditions, the crown is placed on the tooth and the cement additions are removed.
Category
Treatment - Other
2
Description
Control group: SSC cemented with Glass ionomer (Meron, VOCCO, Germany). The material is mixed with the right consistency and two-thirds of the SSC is filled with cement. After drying the tooth under suitable isolation conditions, the crown is placed on the tooth and the cement additions are removed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz dental faculty
Full name of responsible person
Amir Reza Jamei Khosroshahi
Street address
Golgasht st, Tabriz University of Medical Sciences, Faculty of Dentistry, Pediatric dentistry department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
Arj1375.ar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht st., Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Vafaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah st, Tabriz university of medical sciences, Faculty of dentistry, Pediatric dentistry department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
alivafaiitbzmed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Vafaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht st, Tabriz University of Medical Sciences, Faculty of Dentistry, Pediatric dentistry department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
alivafaiitbzmed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Vafaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht st, Tabriz University of Medical Sciences, Faculty of Dentistry, Pediatric dentistry department
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
alivafaiitbzmed@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