Survey of the effect or lack of the effect of sweet nutrient before local anesthetic injection, is the subject of this study.
fifty healthy and cooperative (class III or IV Frankle) 8-10 years old children who admitted in department of pediatrics of shiraz dentistry school that need to extraction of bilateral maxillary canine are selected. inclusion criteria of this study is: Need to extraction of bilateral maxillary primary canine; No history of post traumatic stress disorders or specific phobia related to dental settings; No history of abscess, redness and fistula in injection site; No allergy to lidocaine. Design of the study is split mouth, so that the child before injection the local anesthesia in one side, sucrose solution (30%) is received and before the injection of the other side (after 15 minutes), water as placebo is received.
after use of sucrose solution, for prevention of dental caries, patient's mouth is washed. the dentist records the patients’ reaction during injection based on Visual analuge scale and SEM scale( sound, eye, movement).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012224445N3
Registration date:2016-06-26, 1395/04/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-26, 1395/04/06
Registrant information
Name
Mahboobe Ahmadbeigi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 4866
Email address
ahmadbeigim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-07-18, 1395/04/28
Expected recruitment end date
2016-12-18, 1395/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sucrose on reduction of pain during injection of local anesthesia
Public title
Effect of sweet nutrient on reduction of pain during injection of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 8-10 years old pateint; need to extraction of bilateral maxillary primary canine; cooperative Patient (class III or IV Frankle); no history of systemic disease
Exclusion criteria: history of post traumatic stress disorders or specific phobia related to dental settings; history of abscess, redness and fistula in injection site; allergy to lidocaine.
Age
From 8 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The use of block randomization table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Factors influencing health status and contact with health services
Primary outcomes
1
Description
Reduction of pain during injection
Timepoint
Immediately after intervention
Method of measurement
VAS (Visual Analogue Scale) and SEM scale (Sounds,Eye signs and Body Movement)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All participants drink socruse 30% solution first, then local anesthetic gel are received in the buccal mucosa of the maxillary primary canine in intervention side.
Category
Treatment - Drugs
2
Description
Control group: All participants drink water first, then local anesthetic gel are received in the buccal mucosa of the maxillary primary canine in control side.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences, School of Dentistry
Full name of responsible person
Mahboobe Ahmadbeigi
Street address
Department of Pediatric, School of Dentistry, Ghom abad, Ghasrodasht street,Shiraz, Fars, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr Ajami Shabnam
Full name of responsible person
zahra karanjam
Street address
Vice chancellor for research dental school of Shiraz University of Medical Sciences, Qasrodasht street, ghomabad, Shiraz, Fars, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr Ajami Shabnam
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
Shiraz University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Mahboobe Ahmadbeigi
Position
Pediatric dentistry assistant
Other areas of specialty/work
Street address
Department of Pediatric, School of Dentistry, Ghom abad, Ghasrodasht street,Shiraz, Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 0800
Fax
Email
ahmadbeigim@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences ,Faculty of Dentistry
Full name of responsible person
Faeze Ghaderi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Pediatric, School of Dentistry, Ghom abad, Ghasrodasht street,Shiraz, Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 0800
Fax
Email
faezeghaderi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Dentistry
Full name of responsible person
Mahboobe Ahmadbeigi
Position
Pediatric dentistry assistant
Other areas of specialty/work
Street address
Department of Pediatric, School of Dentistry, Ghom abad, Ghasrodasht street,Shiraz, Fars, Iran
City
Shiraz
Postal code
Phone
+98 71 3627 4866
Fax
Email
ahmadbeigim@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)