this study aimed to assess the clinical and radiographic success of pulpotomy with diode laser and three different remineralizing capping agents.
Design
This split-mouth double-blind randomized clinical trial evaluated 30 children between 3-8 years
Settings and conduct
This split-mouth double-blind randomized clinical trial evaluated 30 children between 3-8 years presenting to the Pediatric Dentistry Department of School of Dentistry, Shahed University of Medical Sciences
Participants/Inclusion and exclusion criteria
The clinical and radiographic inclusion criteria were: children requiring pulpotomy for 3 primary molars due to severe caries, with no swelling or fistula, no sensitivity to percussion, and no mobility or sinus tract. Also, the teeth had to be vital and restorable with stainless steel crowns (SSCs).
no periapical or furcation radiolucency, no internal/external root resorption, no periodontal ligament widening, and physiological root resorption not exceeding more than one-third of the root length
Intervention groups
The teeth were randomly divided into three groups. diode laser with red light was used after hemostasis. The tip of the output nozzle was positioned over the pulp chamber with 2 mm distance from the canal orifice (non-contact mode), and laser was irradiated for 2 min and 15 s at 4 J/cm2 energy density. The pulp chamber was then capped with CH in group 1, MTA in group 2, CEM in group 3 followed by reinforced zinc oxide eugenol (ZOE) and the tooth received a SSC.
Main outcome variables
The clinical and radiographic success rate in pulpotomized primary molars
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200328046884N1
Registration date:2021-06-29, 1400/04/08
Registration timing:retrospective
Last update:2021-06-29, 1400/04/08
Update count:0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Fateme Taghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5542 4577
Email address
taghizadefateme@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2017-12-06, 1396/09/15
Actual recruitment start date
2017-10-22, 1396/07/30
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
2020-12-20, 1399/09/30
Scientific title
Clinical and radiographic assessment of the success of pulpotomy of primary molars with diode laser and three different capping agents
Public title
mineral trioxide aggregate(MTA), calcium-enriched mixture (CEM) cement and Calcium hydroxide in pulpotomized primary molar with laser
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
mental and physical health
Exclusion criteria:
uncooperative child or parents
Age
From 3 years old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
3
three primary molar per person
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
3
three primary molar per person
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Persian Gulf Highway (Tehran - Qom), facing the holy shrine Imam Khomeini, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.Shahed.REC.1396.91
Health conditions studied
1
Description of health condition studied
primary molar pulpotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical and radiographic assessment of the success of pulpotomy of primary molars
Timepoint
The teeth were evaluated clinically and radiographically before treatment and after 9, 18 and 36 months by a pediatric dentist who was blinded
Method of measurement
Zurn and Seale scale
Secondary outcomes
empty
Intervention groups
1
Description
Category
empty
2
Description
Intervention group: In group 1, diode laser with red light (Mustang 2000; Russia), KLO4 output nozzle with 0.5 cm2 cross-sectional area, 30 mW maximum power, and 632 nm continuous-wave mode was used after hemostasis. The tip of the output nozzle was positioned over the pulp chamber with 2 mm distance from the canal orifice (non-contact mode), and laser was irradiated for 2 min and 15 s at 4 J/cm2 energy density. The pulp chamber was then capped with CH followed by reinforced zinc oxide eugenol (ZOE) and the tooth received a SSC. In group 2, laser was irradiated after hemostasis as explained for group 1, and then CEM cement (Bionique Dent, Tehran, Iran) was applied over the pump chamber followed by reinforced ZOE and the tooth received a SSC.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Dentistry Department of School of Dentistry, Shahed University of Medical Sciences
Full name of responsible person
fateme taghizade
Street address
w. Italy St
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 8895 9210
Email
taghizadefateme@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
ِDr Zahra Kiasalari
Street address
Persian Gulf Highway (Tehran - Qom), facing the holy shrine Imam Khomeini, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
5
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
Shahed University
Full name of responsible person
Roza Haghgoo
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
W. Italy street
City
Tehran
Province
Tehran
Postal code
18155/159
Phone
+98 21 5121 5080
Email
taghizadefateme@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Roza Haghgoo
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
W. Italy street
City
Tehran
Province
Tehran
Postal code
18155/159
Phone
+98 21 5121 5080
Email
haghgoodent@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Roza Haghgoo
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
W. Italy street
City
Tehran
Province
Tehran
Postal code
18155/159
Phone
+98 21 5121 5080
Email
Taghizdefateme@gamil.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