Comparison of the effect of dental injuries due to trauma during electroconvulsive therapy with cotton roll and prefabricated mouth guard protection
Design
This study will be performed as a clinical trial with a control group with parallel single-blind randomized groups on 30 patients. A random number table in sealed envelopes will be used for randomization. patients will be divided in two groups intervention group( prefabricated mouth guard ) and control group (cotton roll between teeth)
Settings and conduct
Two checklists are prepared for each patient to record data before and after ECT. All patients will be examined by a single dentist. All teeth, including healthy, root treated, deep and superficial caries, deep amalgam and composite restorations, are recorded in the checklist. If a teeth is not maintainable, the patient will be informed to be fully examined and necessary measures to reduce the risk of aspiration during the ECT process. During ECT, a cotton roll or prefabricated protector will be used according to the group. Examination after ECT is performed by the same dentist and he is not aware of the grouping, and again after ECT, he will record fracture, loose teeth and filled teeth separately in the checklist. Normally, cotton rolls are used for these patients, so this group is considered as the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with psychological disorder needing ECT and having at least 20 teeth
exclusion criteria: Major temporomandibular disorders and patients unable to cooperate
Intervention groups
1- intervention group: prefabricated mouth guard
2- control group: cotton roll between teeth
Main outcome variables
Fractured teeth, loosening of teeth or increase in loosening degree and fracture of filled teeth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210822052251N3
Registration date:2022-07-21, 1401/04/30
Registration timing:prospective
Last update:2022-07-21, 1401/04/30
Update count:0
Registration date
2022-07-21, 1401/04/30
Registrant information
Name
Neda Yasamineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 4991
Email address
yasamineh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-01, 1401/05/10
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dental injuries due to trauma during electroconvulsive therapy with cotton roll and prefabricated mouthguard protection
Public title
Comparison of the effect of dental injuries due to trauma during electroconvulsive therapy with cotton roll and prefabricated mouthguard protection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient or legal guardian having consent to participate
Having psychological disorders needing electroconvulsive therapy
Having at least 20 teeth
Exclusion criteria:
Major temporomandibular disorder
Patient unable to cooperate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to one of two study groups with the help of a random number table and will receive the intervention of the allocated group. For allocation concealment, the method of sealed opaque envelopes which are numbered sequentially will be used. In this method, each random sequence is recorded on a card. Finally, the lids of the letter envelopes will be glued and placed inside a box. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
only the dentist examining the teeth will be blind and will not know patients groups and will examine the patients before and after the intervention.
The patient or legal guardian won't be blind because the intervention is recognizable, though the allocation will be randomized.
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
Vice chancellor of research, Tabriz university of medical sciences, Golghasht avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.TBZMED.REC.1401.222
Health conditions studied
1
Description of health condition studied
patients needing electroconvulsive shock therapy
ICD-10 code
F33.3
ICD-10 code description
Primary outcomes
1
Description
tooth fracture
Timepoint
immediately after intervention
Method of measurement
clinical examination and counting teeth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of pre-fabricated mouthguard
Category
Treatment - Devices
2
Description
Control group: Use of cotton roll
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Razi hospital
Full name of responsible person
Seyed Gholamreza Nourazar
Street address
Razi training Center, Shahid Bakeri boulevard (Elgoli)
City
Tabriz
Province
East Azarbaijan
Postal code
Phone
+98 41 3380 4486
Email
Razi.Hospital@tbzmed.ac.ir
Web page address
https://prazif.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Vice chanselor for research, No 2 Central Building, Tabriz University of Medical Sciences, Golghasht Street
City
Tabiz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.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
Neda Yasamineh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Entrance 4, Tabriz university of medical sciences, Golghasht avenue