Purpose: This study compared the clinical success rates of a new reversed metal post technique and 2 conventional methods for restoration of maxillary primary incisors with extensive carious lesions.
Methods: A total of 161 pulpectomized, severely decayed maxillary primary teeth, in 54 2- to 4-year-old patients presenting with early childhood caries, were randomly treated with 3 different restorative techniques: 53 composite post restorations, 54 fiber post restorations, and 54 reversed post restorations. Single-blind evaluations were made, according to the World Dental Federation criteria, at 3-, 6-, 9-, and 12-month intervals. Data were analyzed using nonparametric tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102105801N1
Registration date:2011-04-24, 1390/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-24, 1390/02/04
Registrant information
Name
Raha Kowsari Isfahan
Name of organization / entity
Isfahan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1662 7295
Email address
rkowsari@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, school of dentistry
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative invivo evaluation of different reconstruction techniques for severely destroyed primary anterior teeth.
Public title
Comparison of different techniques for primary anterior teeth reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Child with no medical or mental disorder.
2- Primary anterior teeth with early childhood caries (ECC) or fracture due to trauma involving 3/4 of the crown.
3- Sound root structure and no caries of the root dentin, with sufficient amount of root structure present (1/3 external root resorption maximally).
4- No mobility.
5- No gingival recession/ gingivitis/ sinus tract
6- No trauma from occlusion as in crossbite, deepbite, etc.
7- No hypoplasia of teeth.
8- No deleterious oral habits.
Age
From 2 years old to 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
161
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Faculty of dentistry, Isfahan University of Medical Sciences, Hezarjarib Street
City
Isfahan
Postal code
8174673461
Approval date
2010-06-20, 1389/03/30
Ethics committee reference number
389337
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
Restoration fracture
Timepoint
3 months after intervention up to one year
Method of measurement
FDI criteria
2
Description
Tooth fracture
Timepoint
3 months after intervention up to one year
Method of measurement
FDI criteria
3
Description
Marginal discoloration
Timepoint
3 months after intervention up to one year
Method of measurement
FDI criteria
4
Description
Restoration retention
Timepoint
3 months after intervention up to one year
Method of measurement
FDI criteria
5
Description
Color match
Timepoint
3 months after intervention up to one year
Method of measurement
FDI criteria
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: 53 composite post
Category
Treatment - Other
2
Description
Group 2: 54 fiber post
Category
Treatment - Other
3
Description
Group 3: 54 reverse prefabricated metal post
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school, Isfahan University of Medical Sciences
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental school, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Abbasali Khademi
Street address
Hezar jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental school, Isfahan 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
Name of organization / entity
Dental school, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Raha Kowsari Isfahan
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric dentistry department, dental school, Isfahan University of Medical Sciences, Hezarjarib Street
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2891
Fax
+98 31 1668 7080
Email
raha_kowsari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Alireza Eshghi
Position
MS of pedodontics, associated professor of dental faculty, Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Pediatric dentistry department, dental school, Isfahan University of Medical Sciences, Hezarjarib Street
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2891
Fax
+98 31 1668 7080
Email
areshghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Raha Kowsari Isfahan
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Pediatric dentistry department, dental school, Isfahan University of Medical Sciences, Hezarjarib Street
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)