Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion
April 30, 2024 updated by: Alaa Ahmed Lotfy Mohamed Saleh, Cairo University
Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain Associated With Dental Injections (Infiltration) Prior to Extraction in 6-8 Years Old Children In Comparison to Topical Anesthesia. (RCT)
This study aims to assess Effectiveness of Pre-administered Natural Sweet-tasting Solution (honey) for Decreasing Pain Associated with Dental Injections (infiltration) prior to dental extraction in 6-8 years old healthy Children (first dental visit) In comparison to topical anesthesia.
Study Overview
Detailed Description
The administration of local anesthetics is one of the most dreaded or anxiety-inducing triggers in a dental setup.
Patients, particularly children, may be fearful of dental injections, which may prevent them from seeking dental treatment.
Even though profound local anesthesia aids in the treatment of pediatric patients in terms of reducing their anxiety and pain during restorative and surgical procedures, the fear of needles has been cited as a barrier to develop proper dental care.
Numerous techniques have been researched in an attempt to minimize the pain and distress associated with these dental injections, varying from localized methods to distraction techniques.
The localized methods include application of topical agents, altering the rate of injection, increasing the pH of local anesthetics by buffering and pretreatment with lasers.
Instruments such as CCLA System (computer-controlled local anesthetic delivery system) and dental vibe are also available to make dental injections more comfortable.
Studies have found that sweet flavored solutions, mainly 30% sucrose, given orally prior to cutaneous procedures can reduce discomfort in neonates undergoing heel sticks and venipuncture.
Effectiveness of sucrose in the treatment of, procedural pain in newborns and babies has been verified in a Cochrane reviews.
Study Type
Interventional
Enrollment (Estimated)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alaa Ahmed Mohamed, B.D.
- Phone Number: 01126160975
- Email: alaasalah199623@gmail.com
Study Contact Backup
- Name: Soad abdelmoniem, Professor
- Phone Number: 01005654355
- Email: soad.abdelmoniem@dentistry.cu.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Children within the age group 6 to 8 years were selected since the cognitive skills necessary for the use of visual analogue scale for pain assessment have not developed in children younger than 6 years of age.
- Mobile deciduous second molars bilaterally that could be treated under infiltration anesthesia.
Exclusion Criteria
- History of allergy to any components of local anesthetic agents used during the study.
- Dental or dentoalveolar abscess.
- Presence of any underlying systemic disease.
- Immunocompromised patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Effect of Pre-administered honey for Decreasing Pain of Dental Injections
The participants were asked to drink 5 mL of honey solution before injecting on the experimental side, the patient was asked to hold the solution in the mouth for a minute and then to spit it out .
|
analgesic effect of honey
|
|
Other: topical anesthesia
benzocaine 20% gel was applied to the test sites on side of the jaw with a cotton tip applicator which was completely soaked for a period of 5 minutes.
|
analgesic effect of honey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain perception during Dental injection Dental injection Pain perception during Dental injection
Time Frame: 1 year
|
Wong-Baker ratting scale 0 happy ,2 hurts a little bit,4 "hurts a little more"6 hurts even more,8 hurts a whole lot"10hurts worst" Rating scale Wong-Baker Rating scale
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child behavior during dental injection
Time Frame: 1 year
|
The SEM(sound, eye, motor) scale Scale from (0-4)
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
heart rate during dental injection
Time Frame: through study completion, an average of 1 year".
|
Pulse oximeter
|
through study completion, an average of 1 year".
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nourhan Omar Elgebaly, Lecturer, Outpatient clinic, department of Pediatric Dentistry, Faculty of Dentistry, Cairo University.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Janiani P, Gurunathan D. Effectiveness of Pre-administered Natural Sweet-tasting Solution for Decreasing Pain Associated with Dental Injections in Children: A Split-mouth Randomized Controlled Trial. J Contemp Dent Pract. 2021 Dec 1;22(12):1434-1437.
- Gumus H, Aydinbelge M. Evaluation of effect of warm local anesthetics on pain perception during dental injections in children: a split-mouth randomized clinical trial. Clin Oral Investig. 2020 Jul;24(7):2315-2319. doi: 10.1007/s00784-019-03086-6. Epub 2019 Oct 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
April 23, 2024
First Submitted That Met QC Criteria
April 26, 2024
First Posted (Actual)
May 1, 2024
Study Record Updates
Last Update Posted (Actual)
May 2, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- pain of dental injection pedo
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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