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Completed

NCT Number: NCT05727527

Effect of a Candy Flavoring Before Local Anesthesia on Anxiety and Pain Perception in Children

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.

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Key information

Conditions

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ola B. Al-Batayneh

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Local Anesthesia 1

Procedure

Local anesthesia injection after applying a candy flavor

Local Anesthesia 2

Procedure

Local anesthesia injection after applying sterile water

Primary outcomes

  1. Pain score

    Time frame: During injection

    Reported pain by the child will be assessed using the Wong-Baker Faces Pain Rating Scale, Scores range from 0-10, higher scores mean more pain

Secondary outcomes

  1. Anxiety

    Time frame: Before and during injection

    Anxiety will be assessed through pulse rate measurements recorded before, during and the injection using a fingertip pulse oximeter.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 14, 2023
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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