Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion

NCT06393777 | Not Yet Recruiting

• 1 other identifier: pain of dental injection pedo
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Analgesia

Keywords

honey; injection; local anesthesia; pain

Outcome Measures

Primary Outcomes (1)

• Pain perception during Dental injection Dental injection Pain perception during Dental injection

  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 Outcomes (1)

• Child behavior during dental injection

  1 year

Other Outcomes (1)

• heart rate during dental injection

  through study completion, an average of 1 year".

Study Arms (2)

Effect of Pre-administered honey for Decreasing Pain of Dental Injections

EXPERIMENTAL

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 .

Dietary Supplement: honey

topical anesthesia

OTHER

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.

Dietary Supplement: honey

Interventions

honey DIETARY_SUPPLEMENT

analgesic effect of honey

Effect of Pre-administered honey for Decreasing Pain of Dental Injections; topical anesthesia

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• 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.

  PMID: 35656683 BACKGROUND

• 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.

  PMID: 31650314 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Honey

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Nourhan Omar Elgebaly, Lecturer

  Outpatient clinic, department of Pediatric Dentistry, Faculty of Dentistry, Cairo University.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Ahmed Mohamed, B.D.

CONTACT

01126160975; alaasalah199623@gmail.com

Soad abdelmoniem, Professor

CONTACT

01005654355; soad.abdelmoniem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This research will be a double blinded study, where the patient (participant) and the statistician will be blind to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: This trial is a randomized clinical trial (parallel design 1:1).

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 1, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04