Comparison of effect of diode laser, astringent paste, and subgingival cord on gingival retraction during impression using a 3D intraoral scanner: a randomized clinical trial
To compare the effect of diode laser, astringent paste, and subgingival cord on gingival retraction during impression using a 3D intraoral scanner
Design
This is a randomized clinical trial, phase II, in which 45 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients need dental veneers referring to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Tooth decay,
The need for dental veneers,
Exclusion criteria:
Inadequate oral hygiene,
Periodontal disease
Intervention groups
Intervention group 1:
Preparing and cutting teeth and applying temporary resin crown with hidden edges using a 980 nm diode laser with a tip of half a millimeter with a low power of 0.7 to 2 W
Intervention Group 2:
Preparing and cutting teeth and applying temporary resin crown with hidden edges using gum threads inside the gingival groove
Intervention Group 3:
Preparing and cutting teeth and applying temporary resin crown with hidden edges using an astringent paste to cover the gingival groove
Main outcome variables
Primary outcome:
Gingival retraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N359
Registration date:2020-06-08, 1399/03/19
Registration timing:retrospective
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of diode laser, astringent paste, and subgingival cord on gingival retraction during impression using a 3D intraoral scanner: a randomized clinical trial
Public title
Comparison of effect of diode laser, astringent paste, and subgingival cord on gingival retraction during impression using a 3D intraoral scanner
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Tooth decay,
The need for dental veneers,
Exclusion criteria:
Inadequate oral hygiene,
Periodontal disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention 1" on one sheet and "intervention 2" on the second sheet and “intervention 3” on the third one. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.UMSHA.REC.1398.719
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
Gingival retraction
Timepoint
Before the intervention and immediately after that
Method of measurement
Using a 3D intraoral scanner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Preparing and cutting teeth and applying temporary resin crown with hidden edges using a 980 nm diode laser with a tip of half a mm with low power of 0.7 to 2 W
Category
Treatment - Other
2
Description
Intervention Group 2: Preparing and cutting teeth and applying temporary resin crown with hidden edges using gum threads inside the gingival groove
Category
Treatment - Other
3
Description
Intervention Group 3:Preparing and cutting teeth and applying temporary resin crown with hidden edges using an astringent paste to cover the gingival groove
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Seyed Farzad Kohnepoushi
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_kohnepoushi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Farzad Kohnepoushi
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_kohnepoushi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Fariborz Vafaee
Position
Dental Prosthesis Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fvafaee@umsah.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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