Clinical trial NCT06393777: Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Analgesia
Keywords: honey
injection
local anesthesia
pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is a randomized clinical trial (parallel design 1:1).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Mobile deciduous second molars bilaterally that could be treated under infiltration anesthesia.

Exclusion Criteria

1. History of allergy to any components of local anesthetic agents used during the study.
2. Dental or dentoalveolar abscess.
3. Presence of any underlying systemic disease.
4. Immunocompromised patients.

Primary outcomes:
measure: Pain perception during Dental injection Dental injection Pain perception during Dental injection
timeFrame: 1 year
Secondary outcomes:
measure: Child behavior during dental injection
timeFrame: 1 year
Other outcomes:
measure: heart rate during dental injection
timeFrame: through study completion, an average of 1 year".
Locations:
Study officials:
affiliation: Outpatient clinic, department of Pediatric Dentistry, Faculty of Dentistry, Cairo University.
name: Nourhan Omar Elgebaly, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.