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Evaluating the efficacy of oral sweet taste in making dental treatment of 4-6 years old children more pleasant

Protocol summary

Study aim
Evaluating the efficacy of oral sweet taste in making dental treatment of 4-6 years old children more pleasant
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized on 40 patients, a simple randomization method with a sealed envelope
Settings and conduct
Patients of pediatric ward of Qazvin Dental School are included in the study according to the inclusion and exclusion criteria. The oral environment of the intervention group is maintained sweet with a solution of 25% sucrose and honey before and during the treatment. Water is used in the control group. After preparing the child, the evaluator meets him (blinding of the evaluator) and the data is provided to the statistical analyst in the form of group code (blinding of the analyst).
Participants/Inclusion and exclusion criteria
4-6 year old children who need pulp treatment of maxillary primary molar who are healthy and cooperative are included in the study. In case of any allergy or problem with sweet substances, the presence of spontaneous/night pain or the presence of inflammation in the target tooth, or the lack of proper anesthesia, the patient will be excluded from the study.
Intervention groups
In the intervention group, after anesthesia injection, the child keeps 25% sweet solution in the mouth for one minute and then, honey is placed in the buccal vestibule of the mandible, in the opposite quadrant, with a swab. This operation is repeated every 2 minutes. In the control group, after anesthesia injection, the child keeps normal water in his mouth for one minute and takes it out. During the treatment, a dry swab is drawn in the buccal vestibule on the opposite side of the treatment and this is repeated every two minutes
Main outcome variables
Objective evaluation according to FLACC criteria; Subjective evaluation according to Wong Baker criteria; Heart rate; Degree of blood oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180104038218N4
Registration date: 2022-09-18, 1401/06/27
Registration timing: prospective

Last update: 2022-09-18, 1401/06/27
Update count: 0
Registration date
2022-09-18, 1401/06/27
Registrant information
Name
Razieh Jabbarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3061
Email address
r.jabbarian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of oral sweet taste in making dental treatment of 4-6 years old children more pleasant
Public title
Evaluating the efficacy of oral sweet taste in making dental treatment of 4-6 years old children more pleasant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
4-6 year old children in need of maxillary first molar pulp treatment Physical health in terms of systemic and development positive behavior according to Frankel's classification (cooperative and without resistance to treatment) They should not eat or drink anything at least one hour before the treatment Without previous dental experience
Exclusion criteria:
Allergy or contraindication regarding consumption of sweet substances Spontaneous/nocturnal pain or abscess in the target tooth Presence of pain, inflammation and any other problem in the treatment area If complete anesthesia was not achieved for the treatment, the patient will be excluded from the study
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using an sealed envelope with an equal number of intervention (sweet taste) and control (water) samples is placed in a package and provided to the ward nurse, each time the nurse (Who has no role in the continuation of the study) pulls one of the envelopes and it is determined that the patient receives intervention or control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessment is performed by a person other than the researcher and clinical caregiver and because he / she is present at the patient's bedside after the intervention, he / she is blind to the received intervention. The grouping results of each sample are delivered to the statistical analyzer in the form of numbers, so the analyzer is also blind. According to the sweet taste in the mouth of the intervention group, the participants are not blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2022-08-03, 1401/05/12
Ethics committee reference number
IR.QUMS.REC.1401.131

Health conditions studied

1

Description of health condition studied
treatment in pediatric dentistry
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
The objective level of pleasant treatment
Timepoint
during treatment
Method of measurement
FLACC( Face,leg,activity,crying,consolability)

2

Description
The objective level of pleasant treatment
Timepoint
after treatment
Method of measurement
Wong baker

3

Description
heart rate
Timepoint
before, during and after treatment
Method of measurement
pulse oximeter

4

Description
oxygen saturation
Timepoint
before, during and after treatment
Method of measurement
pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: In the first session, all children are subjected to brushing treatment and fluoride therapy with the tell show do technique in order to evaluate cooperation and shape their behavior. In the next session, the child is randomly assigned to one of the first and second groups and receives dental treatment. In both groups, 2% lidocaine and 1/100,000 epinephrine were used to anesthetize the region with the supra periosteal technique, and the injection syringe was not placed in the child's viewing angle in both groups. In the intervention group, pulp therapy of the maxillary molar is performed in the condition where sweet taste prevails in the mouth; Therefore, after anesthesia injection, the child kept a 25% sweet solution (25 g of sucrose (Merck, Germany) - 75 cc of distilled water) in the mouth for one minute, and then, honey is applied with a swab in the buccal vestibule of the mandible, in the opposite quadrant. If the honey is washed, this process is repeated every 2 minutes
Category
Treatment - Other

2

Description
Control group: Control group: In the first session, all children are subjected to brushing and fluoride therapy with the tell show do technique in order to evaluate cooperation and shape their behavior. In the next session, the child is randomly assigned to one of the first and second groups and receives dental treatment. In both groups, 2% lidocaine and 1/100,000 epinephrine were used to anesthetize the region with the supra periosteal technique, and the injection syringe was not placed in the child's viewing angle in both groups. In the control group, the maxillary molar receives pulp therapy under normal conditions. In control group , after the anesthetic injection, the child holds normal water in his mouth for one minute and then spits it out. During the treatment, a dry swab is drawn in the buccal vestibule on the opposite side of the treatment and this is repeated every two minutes.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin university of medical sciences, faculty of dentistry
Full name of responsible person
Razieh Jabbarian
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mehdi Mirhashemi
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 7777 3333
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Jabbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Jabbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razieh Jabbarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Bahonar Boulvard
City
Qazvin
Province
Qazvin
Postal code
3471976160
Phone
+98 28 3335 3062
Email
r.jabbarian@qums.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
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