Clinical trial NCT05727527: Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children
Official title: The Effect of Using a Sugar-free Candy Flavoring Before Local Anesthesia Injection on Anxiety and Pain Perception in Children: a Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthesia
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 84
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial that aimed to test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception when compared to a negative control group. Applying the flavor before injecting local anesthesia helped in distracting the child and reduced the associated pain.

Detailed description: Background: Distraction techniques can be very useful in managing children on the dental chair and to guide their attention away from a painful stimulus. No studies so far have used a sugar-free solution as a distraction method.

Aim: To test the effect of using sugar-free flavors as a sensory distraction technique during local anesthesia on pain perception and anxiety when compared to negative control group, using a split-mouth randomized study design.

Methods: A total of 84 children, aged 4-9 years with no previous dental experience and require the same treatment on the upper primary first or second molars bilaterally were included in this study. Each child received two injections. The children were randomly allocated into two groups, group 1 received the first injection after applying a flavor, and group 2 received the first injection after applying sterile water. The children received the first injection either on the right or left side, and switched sides on the next visit, resulting in (n=168) total injections. The observed pain perception was assessed using the SEM scale. Wong-Baker Faces pain rating scale will be used to assess the pain reported by the child. Pulse rate, BMI, and sweet taste preference were also recorded by an independent observer to ensure blinding.

Results: Using a sugar-free candy flavor before injecting local anesthesia helps in reducing pain accompanying local anesthesia.

Eligibility criteria: Inclusion Criteria:

* Healthy (ASA Grade 1 status) children
* First dental experience for the child including local anesthesia.
* Children with caries lesions that require restorative treatment.
* Children who require the same treatment on upper primary first or second molars bilaterally.

Exclusion Criteria:

* Children with poor behavior (unable to cooperate for dental treatment).
* Previous unpleasant dental experience (dental phobia).
* History of abscess, redness, fistula in the injection site (need for extraction).
* Presence of a systemic disease, mental, cognitive and intellectual disabilities.

Primary outcomes:
measure: Pain score
timeFrame: During injection
Secondary outcomes:
measure: Anxiety
timeFrame: Before and during injection
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Ola B. Al-Batayneh
Study officials:
affiliation: Jordan University of Science and Technology
name: Ola B. Al-Batayneh
role: PRINCIPAL_INVESTIGATOR
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