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Local AnesthesiaNCT05727527

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

A study testing Local Anesthesia 1 and Local Anesthesia 2 in people with Local Anesthesia, run by King Abdullah University Hospital at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Local Anesthesia
What is being tested?
Local Anesthesia 1 and Local Anesthesia 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteJordan
Study dates
1 Apr 2022to 1 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Ola B. Al-Batayneh

    Irbid, 22110

Other trials in Jordan

About this study

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

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.

Read the 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.

Being tested
Local Anesthesia 1, Local Anesthesia 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local Anesthesia 1Procedure or surgery

    Local anesthesia injection after applying a candy flavor

  • Local Anesthesia 2Procedure or surgery

    Local anesthesia injection after applying sterile water

Study groups in NCT05727527
Study groupRoleWhat they receive
Study groupActive comparatorWill initially receive the infiltration injection after applying a candy flavor first, followed by sterile water in the next visit
Receives: Procedure: Local Anesthesia 1; Procedure: Local Anesthesia 2
Control groupActive comparatorWill initially receive the infiltration injection after applying sterile water first, followed by candy flavor in the next visit
Receives: Procedure: Local Anesthesia 1; Procedure: Local Anesthesia 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

    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

    Measured: During injection

Secondary outcomes (1)

  1. Anxiety

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

    Measured: Before and during injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start1 Apr 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727527
Sponsor's protocol ID
692l2021
Status last verified
May 2024
First submitted
5 Feb 2023
Last updated
6 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alanazi KJ, Pani S, AlGhanim N. Efficacy of external cold and a vibrating device in reducing discomfort of dental injections in children: A split mouth randomised crossover study. Eur Arch Paediatr Dent. 2019 Apr;20(2):79-84. doi: 10.1007/s40368-018-0399-8. Epub 2018 Dec 5.

    PubMed 30519955

  • Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.

    PubMed 27409593

  • Asvanund Y, Mitrakul K, Juhong RO, Arunakul M. Effect of audiovisual eyeglasses during local anesthesia injections in 5- to 8-year-old children. Quintessence Int. 2015 Jun;46(6):513-21. doi: 10.3290/j.qi.a33932.

    PubMed 25918755

  • Ghaderi F, Ahmadbeigi M, Vossoughi M, Sardarian A. The efficacy of administrating a sweet-tasting solution for reducing the pain related to dental injections in children: A randomized controlled trial. Int J Paediatr Dent. 2021 Mar;31(2):184-190. doi: 10.1111/ipd.12697. Epub 2020 Aug 25.

    PubMed 32757418

  • Ghadimi S, Estaki Z, Rahbar P, Shamshiri AR. Effect of visual distraction on children's anxiety during dental treatment: a crossover randomized clinical trial. Eur Arch Paediatr Dent. 2018 Aug;19(4):239-244. doi: 10.1007/s40368-018-0352-x. Epub 2018 Jun 12.

    PubMed 29949082

  • Jones CM, Heidmann J, Gerrish AC. Children's ratings of dental injection and treatment pain, and the influence of the time taken to administer the injection. Int J Paediatr Dent. 1995 Jun;5(2):81-5. doi: 10.1111/j.1365-263x.1995.tb00169.x.

    PubMed 7547818

  • Nuvvula S, Alahari S, Kamatham R, Challa RR. Effect of audiovisual distraction with 3D video glasses on dental anxiety of children experiencing administration of local analgesia: a randomised clinical trial. Eur Arch Paediatr Dent. 2015 Feb;16(1):43-50. doi: 10.1007/s40368-014-0145-9. Epub 2014 Sep 26.

    PubMed 25256207

  • Srouji R, Ratnapalan S, Schneeweiss S. Pain in children: assessment and nonpharmacological management. Int J Pediatr. 2010;2010:474838. doi: 10.1155/2010/474838. Epub 2010 Jul 25.

    PubMed 20706640

  • Pepino YM, Mennella JA. Sucrose-induced analgesia is related to sweet preferences in children but not adults. Pain. 2005 Dec 15;119(1-3):210-218. doi: 10.1016/j.pain.2005.09.029. Epub 2005 Nov 18.

    PubMed 16298489

  • Al-Batayneh OB, Abu-Abbas R, Al-Saleh M. Efficacy of administering a sugar-free flavor before dental injections on pain perception in children: A split-mouth randomized crossover clinical trial. Int J Paediatr Dent. 2024 Nov;34(6):915-924. doi: 10.1111/ipd.13191. Epub 2024 Apr 16.

    PubMed 38627933

Questions about this trial

What is this clinical trial studying?

A study testing Local Anesthesia 1 and Local Anesthesia 2 in people with Local Anesthesia, run by King Abdullah University Hospital at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: During injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05727527, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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