Dental AnxietyNCT05883566
Comparison of Dental Pain Response in Children
A study testing experimental in people with Dental Anxiety, run by Altamash Institute of Dental Medicine at 2 sites in Pakistan.
Trial summary
Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 May 2023to 30 Jun 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range: Children aged between 6-12 years old (or any other specific age range) will be included in the study.
- Dental pain: Participants who have been diagnosed with dental pain by their dentist will be included.
- Consent: Informed consent must be obtained from the child and their parents or guardians before the study.
Who cannot join
- Participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression.
- Participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain
Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure.
- Conditions
- Dental Anxiety
- Being tested
- experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentalBehavioural
During the procedure, the chairside assistant can capture video recordings of the child's behavior and facial expressions. These videos can be later reviewed by a trained observer who can evaluate the child's pain experience
| Study group | Role | What they receive |
|---|---|---|
| behaviour | Experimental | Not described Receives: Behavioral: experimental |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Analysis of pain after the treatment pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured
Measured: immediately after completion of the treatment within 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hira Abbasi, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883566
- Sponsor's protocol ID
- Dental Pain in children
- Status last verified
- Sep 2023
- First submitted
- 21 May 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbasi H, Saini RS, Binduhayyim RIH, Kuruniyan MS, Mosaddad SA, Heboyan A. Comparison of behavioural, physiological, and self-reported pain responses in Pakistani children with dental pain: a descriptive cross-sectional study. Eur Arch Paediatr Dent. 2025 Dec;26(6):1181-1192. doi: 10.1007/s40368-025-01090-x. Epub 2025 Aug 3.
PubMed 40753526
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain
- ClinicalTrials.gov ID
- NCT05883566
- Acronym / sponsor ID
- Dental Pain in children
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| behaviour | Experimental | Behavioral: experimental |
| control | No intervention | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age range: Children aged between 6-12 years old (or any other specific age range) will be included in the study.
- Dental pain: Participants who have been diagnosed with dental pain by their dentist will be included.
- Consent: Informed consent must be obtained from the child and their parents or guardians before the study.
Key exclusion criteria (2 listed)
- Participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression.
- Participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimentalDuring the procedure, the chairside assistant can capture video recordings of the child's behavior and facial expressions. These videos can be later reviewed by a trained observer who can evaluate the child's pain experience | Behavioural | behaviour |
Primary outcome
Post operative pain
Time frame: immediately after completion of the treatment within 60 seconds
Analysis of pain after the treatment pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 40753526Abbasi H, Saini RS, Binduhayyim RIH, Kuruniyan MS, Mosaddad SA, Heboyan A. Comparison of behavioural, physiological, and self-reported pain responses in Pakistani children with dental pain: a descriptive cross-sectional study. Eur Arch Paediatr Dent. 2025 Dec;26(6):1181-1192. doi: 10.1007/s40368-025-01090-x. Epub 2025 Aug 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental in people with Dental Anxiety, run by Altamash Institute of Dental Medicine at 2 sites in Pakistan.
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 3 inclusion and 2 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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Post operative pain (time frame: immediately after completion of the treatment within 60 seconds). 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 NCT05883566, which also lists 1 linked publication.
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 11 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.