Evaluating the effectiveness of indirect pulp capping of permanent molars using Protooth fast-setting calcium silicate cement and calcium hydroxide cement
Evaluating the effectiveness of indirect pulp capping of permanent molars using Protooth fast-setting calcium silicate cement and calcium hydroxide cement
Design
This study is designed as a split-mouth and the teeth will be intervened bilaterally in one person. One side will be randomly, flip the coin, capped with calcium hydroxide and the other tooth with protooth. In this study, the groups are parallel and the sample size of 124 teeth will be randomly divided into two groups of 62 teeth. This study will be double blind.
Settings and conduct
Tabriz dental faculty. All clinical procedures will be carried out by a post-graduate student of pediatric dentistry. The teeth will be randomly divided into two groups. On the teeth of the first group, protooth (Dentosolve, Aarhus, Denmark) is placed on the pulp floor with a thickness of 2 mm by the instrument and covered by wet cotton for 3 minutes. In the control group, a thin layer of calcium hydroxide cement (Hydro-C, Dentsply, York, PA, USA) is placed in the area by a condenser with a round end. Finally, the teeth are restored with composite.
Participants/Inclusion and exclusion criteria
Children with at least 2 permanent molars with active caries near the pulp on both sides of the jaw that require pulp coverage and restoration.
Intervention groups
This study is designed as a split-mouth and the teeth will be intervened bilaterally in one person. One side will be randomly capped with calcium hydroxide and the other tooth with protooth.
Main outcome variables
Absence of spontaneous and persistent pain; Absence of abscess or periapical fistula; Absence of sensitivity to Percussion test and chronic or acute periodontal inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161227031608N4
Registration date:2023-11-05, 1402/08/14
Registration timing:prospective
Last update:2023-11-05, 1402/08/14
Update count:0
Registration date
2023-11-05, 1402/08/14
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
Evaluating the effectiveness of indirect pulp capping of permanent molars using Protooth fast-setting calcium silicate cement and calcium hydroxide cement
Public title
Evaluating the effectiveness of indirect pulp capping of permanent molars using Protooth fast-setting calcium silicate cement and calcium hydroxide cement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with at least 2 permanent molars with active caries near the pulp (with no pulp exposure) on both sides of the jaw
Teeth required pulp coverage and restoration.
Exclusion criteria:
Teeth with spontaneous pain
Teeth with abscess or periapical fistula
Age
From 6 years old to 12 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
62
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient must have at least 2 permanent molars with active caries on both sides to be randomly pulp capped with calcium hydroxide on one side and protooth the other side.
Randomization (investigator's opinion)
Randomized
Randomization description
Since the study will be split-mouth, by default, to randomize the treatments, the type of treatment for the teeth on the right side of the jaw arch will be determined by the "Flip the coin" method. The teeth on the left side of the jaw arch are in the second group and will receive another type of treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Another pediatric dentist with more than 10 years of experience who is unaware of the type of used substance, will judge the results without prior knowledge of the performed treatments as a third person.
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
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-04-16, 1402/01/27
Ethics committee reference number
IR.TBZMED.REC.1402.053
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
Spontaneous and persistent pain
Timepoint
Once 6 months after treatment
Method of measurement
Clinical examination
2
Description
Absence of abscess or periapical fistula
Timepoint
Once 6 months after treatment
Method of measurement
Clinical examination
3
Description
Absence of sensitivity to Percussion test and chronic or acute periodontal inflammation
Timepoint
Once 6 months after treatment
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Protooth (Dentosolve, Aarhus, Denmark) is placed on the teeth with a 2 mm thick instrument and covered with wet cotton for 3 minutes. Then 2 mm thick glass ionomer cement (Fuji II, GC, America) is placed and cured for 20 seconds (Astralis 10, 650 mW/cm2, Ivoclar Vivadent, Schaan, Liechtenstein). Finally, the teeth are restored with composite.
Category
Treatment - Other
2
Description
Intervention group 2: A thin layer of calcium hydroxide cement (Hydro-C, Dentsply, York, PA, USA) is placed on the teeth by a condenser with a round end. Then 2 mm thick glass ionomer cement (Fuji II, GC, America) is placed. is given and cured for 20 seconds (Astralis 10, 650 mW/cm2, Ivoclar Vivadent, Schaan, Liechtenstein).Finally, the teeth are restored with composite.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz dental faculty
Full name of responsible person
Seyyede Shabnam Sajjadi
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
shabnam.sj97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice Chancellor of Research and Technology
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
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 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
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
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