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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06393777
Other study ID # pain of dental injection pedo
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date October 2025

Study information

Verified date April 2024
Source Cairo University
Contact Alaa Ahmed Mohamed, B.D.
Phone 01126160975
Email alaasalah199623@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 14
Est. completion date October 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
honey
analgesic effect of honey

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other heart rate during dental injection Pulse oximeter through study completion, an average of 1 year".
Primary 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 Child behavior during dental injection The SEM(sound, eye, motor) scale Scale from (0-4) 1 year
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