Investigating the effect of forceps physics on complications after tooth extraction.
Design
This study is clinical trial. 26 patients at Arak Dental School are divided into two groups of 13 subjects. They are divided into standard and intervention groups.This study is double blind. Participant and analyzer are blind (double blind).Participant and analyzer don't aware from grouping.
Settings and conduct
26 patients at Arak Dental School are included in two groups of 13 subjects. This study is double blind. Participant and analyzer are blind (double blind).Participant and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 to 45 years of both sexes؛ ASA I and II؛ the teeth have 3 millimeters of healthy structure؛ they do not have a local anesthetic ؛not pregnant؛ not have periodontal disease؛ not need an orthodontic؛ no residual root؛ Do not have abnormal teeth.
Exclusion criteria: Persons who do not have the consent to continue studying for any reason
Intervention groups
Sample group: Tooth extraction with physics forceps.Standard group:extraction with conventional forceps and elevator.Forceps Physics Group: Injection of numbness and separation of the gums from the tooth
Main outcome variables
Time for extraction؛ Root fracture ؛Crown Fracture؛ buccal cortical plate fracture؛ soft tissue laceration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181211041933N1
Registration date:2019-01-08, 1397/10/18
Registration timing:retrospective
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Fatemeh Shadorvan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
fatemeh.shadorvan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-03, 1397/05/12
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
2018-08-11, 1397/05/20
Actual recruitment end date
2018-10-21, 1397/07/29
Trial completion date
2018-10-21, 1397/07/29
Scientific title
Comparison of using physics forceps and conventional forceps on post tooth extraction complication
Public title
Comparison of using physics forceps and conventional forceps on post tooth extraction complication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Those who are ASA (American Association of Anesthesiologists) are classified in the I-II Group according to the ASA (*) table.
People whose teeth have a thickness of 3 mm or more and have a healthy structure above the gingival margin level
People who do not have a local anesthetic prescription
People who do not have dental periodontal disease or not have a soft, hard tissue around the teeth
Those who do not need to remove the tooth for orthodontic treatment.
People who do not have the roots left.
Women who are not pregnant or not Postmenopausal
Persons with abnormal dental roots (severe or felonous roots, hyperthermosis roots or internal or external analysis, etc.)
18-45 years
Exclusion criteria:
Persons who do not have the consent to continue studying for any reason
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
28
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number in division of groups in two groups A and B.Randomized patients are divided into two groups.Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomizing gives each participant equal odds for being placed in each of the groups.
The candidate patients who enter the study are randomly assigned to the randomly assigned table of randomly assigned to the two groups.
Individual
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind.Participant and analyzer are blind (double blind).Participant and analyzer don't aware from grouping
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences and Health Services of Markazi Province (Arak
Street address
Shahid Shiroudi Ave., Aalam-e Hoda St., Arak University of Medical Sciences and Health Services
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.ARAKMU.REC.1397.135
Health conditions studied
1
Description of health condition studied
Teeth extraction
ICD-10 code
K02.7
ICD-10 code description
Dental root caries
Primary outcomes
1
Description
Number of broken roots after tooth extraction
Timepoint
after of tooth extraction
Method of measurement
Radiographic image
2
Description
Percentage of broken crowns after tooth extraction
Timepoint
After of tooth extraction
Method of measurement
Radiographic image
3
Description
Percentage of fracture of buccal plate after tooth extraction
Timepoint
after of tooth extraction
Method of measurement
Clinical and radiographic images
Secondary outcomes
1
Description
Time to tooth extraction
Timepoint
Start extraction until the end of the process
Method of measurement
stopwatch
2
Description
Gingival after tooth extraction
Timepoint
After tooth extraction
Method of measurement
Clinical, observation
Intervention groups
1
Description
Intervention group: Forceps Physics whose tool for extraction teeth, making Dana Poya , non-usable, usable for more times and sterilized
Category
Treatment - Devices
2
Description
Control group: conventional forceps,for tooth extraction, manufacture of Joya Company, can be used frequently and sterilized, non-consumable
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as information on the main outcome, and the possibility of result sharing.
When the data will become available and for how long
Get started 1 month after printing results
To whom data/document is available
All people who work in academia, science and industry
Under which criteria data/document could be used
All people who need to use content and analysis.
All researchers and students in dentistry and medicine. It can be used in all theses and proposals and articles.
From where data/document is obtainable
fatemeh.shadorvan@yahoo.com
tell number 09166147318
What processes are involved for a request to access data/document
Email will be sent at least one week after the request.