Clinical trial comparing the effects of standard dental needles and telescopic needles to reduce the pain and anxiety of patients who refer to the dental clinic in Kerman city
1) Objectives: To compare the pain and anxiety associated with dental injection using standard needles and telescopicl needles. 2) Design: New invented telescopic needles with the ability of using of local anesthetic gel and covering the needle appearance compare with standard dental needles in reducing pain and anxiety injection . 3) The 100 patients admitted to the dental clinic were randomly placed in two groups ( intervention and control) and injected with standard needles or telescopic needles and the pain and Anxiety of injection compared between the two groups. 4) Inclusion criteria Participants: Restoration of teeth D and E in children and teeth number 6,7 in adults under local anesthesia ; The ability to communicate with the audience; No specific systemic disease; Patients in the 48 hours prior to treatment have not used any analgesia . 5) Exclusion criteria: patients with underlying systemic problem ; Patients with the disability to communicate with the audience, patients with dental pain; Children in single-parent 6) Interventions: dental pain and anxiety have compared in patients who have used conventional needles and telescopic needles . 7) The main outcome variables: pain after injection checked using the Visual Analogue Scale and anxiety before and after injection examined using Venham Scale questionnaire to assess the effectiveness of the new telescopic dental needles
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015113025300N1
Registration date:2016-01-05, 1394/10/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-05, 1394/10/15
Registrant information
Name
Raha HabibAgahi
Name of organization / entity
Oral and dental research center
Country
Iran (Islamic Republic of)
Phone
+98 917 811 8417
Email address
raha2979@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of standard dental needles and telescopic needles to reduce the pain and anxiety of patients who refer to the dental clinic in Kerman city
Public title
Telescopic coated dental needles vs. conventional syringe system: comparing pain and anxiety in patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: the need for similar dental treatment under local anesthesia (restoration of teeth number D and E in children and teeth number of 6,7 in adults); Ability to speak and communicate with the audience; The lack of any developmental delay; The lack of a specific systemic disease; patients do not have pain when entering the study ; Patients in the 48 hours before the dental work are not analgesics.
Exclusion criteria: patients with speech problems and lack the ability to communicate with the audience; Patients with systemic problem; Single-parent's children ; Patients with a history of dental pain.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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 Kerman University of Medical Sciences
Street address
Tahmasbabad Square
City
Kerman
Postal code
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
IR.KMU.REC.1394.312
Health conditions studied
1
Description of health condition studied
Pain & Anxiety
ICD-10 code
F40, F41,
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Pain
Timepoint
After injection
Method of measurement
Visual Analouge Scale (VAS)
2
Description
Anxiety
Timepoint
Before and after of injection
Method of measurement
Venham's anxiety scale
Secondary outcomes
1
Description
The intrest of patients to refer for later dental procedures
Timepoint
After first dental injecton and treatment
Method of measurement
Questionair
Intervention groups
1
Description
In the intervention group, patients were injected by new telescopic needle that covered the needle appearance during injection, and also by using lidocaine gel before needle insertion, it has the ability to reduce the pain and anxiety during injection .
Category
Behavior
2
Description
In the control group conventional and standard needles were used , and the pain and anxiety induced in this group examined with pain and anxiety questionnaire.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Arya dental clinic
Full name of responsible person
Mr. Ehsan Zamani
Street address
Jahad BLVD. 56-58
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Ms. Hasani
Street address
Tahmasbabad Square
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental and Oral Research Center
Full name of responsible person
Dr. Raha HabibAgahi
Position
Dentist, PhD of dental materials
Other areas of specialty/work
Street address
Kosar BLVD.
City
Kerman
Postal code
Phone
+98 34 3213 3440
Fax
Email
raha2979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Dr. Maryam Hashemippor
Position
Oral and Dental Specialist
Other areas of specialty/work
Street address
Shafa street
City
Kerman
Postal code
Phone
+98 34 3213 3440
Fax
Email
raha2979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental and Oral Research Center
Full name of responsible person
Raha HabibAgahi
Position
Dentist
Other areas of specialty/work
Street address
Kosar BLVD
City
kerman
Postal code
Phone
00
Fax
Email
raha2979@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)