Dental AnxietyECCNCT03566212
Efficacy of Camouflaged Syringe vs Conventional Syringe
A study testing Conventional Syringe and Camouflage Syringe in people with Dental Anxiety and Behavior, run by Sneha D. Suwarnkar at 1 site in India.
Trial summary
This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing Dental Anxiety and increasing behaviour rating.Half of the participants received local anesthesia using camouflaged syringe, while others received using conventional syringe. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Behavior
- What is being tested?
- Conventional Syringe and Camouflage Syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 13 Aug 2017to 30 Aug 2017
- 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- retained teeth,
- badly carious teeth,
- mobile teeth
- requiring a dental procedure under local anesthesia were selected.
Who cannot join
- Mentally challenged children
- those with medical conditions contraindicating the use of local anesthesia and / or surgical procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparative Study of Efficacy of Camouflaged Syringe vs Conventional Syringe in Reducing Dental Anxiety
This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing Dental Anxiety and increasing behaviour rating.Half of the participants received local anesthesia using camouflaged syringe, while others received using conventional syringe.
Read the detailed description
Dental anxiety and phobia result in avoidance of dental care. Since the injection itself can be painful, pain reduction procedures warrant continued investigation. Camouflage design deals with the visual impact of the needle and syringe though the tactile sensation remains unaltered. In our study, post treatment anxiety levels in camouflaged syringe was reduced as compared to conventional syringe group and this might be because, patients with low anxiety tend to have high pain thresholds.
- Conditions
- Dental Anxiety, Behavior
- Being tested
- Conventional Syringe, Camouflage Syringe
- Keywords
- Anxiety, Camouflaged syringe, Conventional syringe
- Medical subject headings
- Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional SyringeDevice
local anesthesia was administered in first group using Conventional syringe
Camouflage SyringeDevice
local anesthesia was administered in second group using Camouflage syringe
| Study group | Role | What they receive |
|---|---|---|
| conventional syringe | Experimental | Individuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe. Receives: Device: Conventional Syringe |
| camouflaged syringe | Experimental | Individuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe. Receives: Device: Camouflage Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels by using the Chotta Bheem and Chutki scale
Anxiety levels in both camouflaged group and conventional group in the children were scored before and after the procedure using the Chotta Bheem and Chutki scale. The Chotta Bheem and Chutki (CBC) scale comprises two separate cards: one for boys and the other for girls. The cartoon characters of Chotta Bheem and Chutki were chosen to depict various emotions for boys and girls respectively. Each card consists of a series of six figures depicting sequentially various emotions from 'happy' to 'unhappy and running away' of the cartoon character. Score 1 is happy face, score 2 is sad face, score 3 is crying face, score 4 is angry face, score 5 is shouting and score 6 is running. So, here, score 1 depicts patient is happy whereas as score increases anxiety level also increases which denotes that patient is unhappy.
Measured: after 5 minutes
Secondary outcomes (1)
Behavior rating by using Frankel Behaviour rating scale
Behavior rating in both camouflaged group and conventional group in the children were scored before and after the procedure using Frankel Behaviour rating scale. Behavior rating scale comprised of scores from definitely negative to definitely positive. 'Double negative'(--) i.e. 'definitely negative' score indicates that patient refuses treatment, 'negative score'(-) indicates that patient is reluctant to accept treatment, there is evidence of negative attitude but not pronounced, ' positive score' (+) indicates that patient accepts treatment though there is cautious with treatment but follows dentist's instructions cooperatively whereas ' definitely positive score' (++) indicates that there is good raport of patient with dentist and accepts the treatment with enjoyment. So, as score increases from definitely negative to definitely positive, behaviour of children also increases.
Measured: after 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start13 Aug 2017
- Primary completion27 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- local anesthesia is administered by using either camouflaged syringe or conventional syringe and was compared for reduction in anxiety levels in both groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sneha D. Suwarnkar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sneha D. Suwarnkar, Saraswati-Dhanwantari Dental College & Hospital
- Investigators
- Sneha D Suwarnkar, MDS, Principal investigator, Saraswati Dhanwantari Dental College and Hospital, Parbhani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566212
- Sponsor's protocol ID
- SaraswatiDhanwantari
- Acronym
- ECC
- Status last verified
- Oct 2018
- First submitted
- 30 May 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it will be dependent on publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Study of Efficacy of Camouflaged Syringe vs Conventional Syringe in Reducing Dental Anxiety
- ClinicalTrials.gov ID
- NCT03566212
- Acronym / sponsor ID
- ECC / SaraswatiDhanwantari
- Conditions
- Dental Anxiety, Behavior
- Keywords
- Anxiety, Camouflaged syringe, Conventional syringe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sneha D. SuwarnkarUniversity, hospital or other
- Study start
- 13 Aug 2017 (actual)
- Primary completion
- 27 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 25 Jun 2018 (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.
This study evaluates the efficacy of Camouflage syringe vs Conventional syringe in reducing Dental Anxiety and increasing behaviour rating.Half of the participants received local anesthesia using camouflaged syringe, while others received using conventional syringe.
Detailed description
Dental anxiety and phobia result in avoidance of dental care. Since the injection itself can be painful, pain reduction procedures warrant continued investigation. Camouflage design deals with the visual impact of the needle and syringe though the tactile sensation remains unaltered. In our study, post treatment anxiety levels in camouflaged syringe was reduced as compared to conventional syringe group and this might be because, patients with low anxiety tend to have high pain thresholds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- local anesthesia is administered by using either camouflaged syringe or conventional syringe and was compared for reduction in anxiety levels in both groups
| Arm | Type | Receives |
|---|---|---|
| conventional syringe | Experimental | Device: Conventional SyringeIndividuals requiring local anesthesia for dental treatment were treated in first group by using conventional syringe. |
| camouflaged syringe | Experimental | Device: Camouflage SyringeIndividuals requiring local anesthesia for dental treatment were treated in second group by using camouflage syringe. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- retained teeth,
- badly carious teeth,
- mobile teeth
- requiring a dental procedure under local anesthesia were selected.
Key exclusion criteria (2 listed)
- Mentally challenged children
- those with medical conditions contraindicating the use of local anesthesia and / or surgical procedures
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 |
|---|---|---|
| Conventional Syringelocal anesthesia was administered in first group using Conventional syringe | Device | conventional syringe |
| Camouflage Syringelocal anesthesia was administered in second group using Camouflage syringe | Device | camouflaged syringe |
Primary outcome
Anxiety levels by using the Chotta Bheem and Chutki scale
Time frame: after 5 minutes
Anxiety levels in both camouflaged group and conventional group in the children were scored before and after the procedure using the Chotta Bheem and Chutki scale. The Chotta Bheem and Chutki (CBC) scale comprises two separate cards: one for boys and the other for girls. The cartoon characters of Chotta Bheem and Chutki were chosen to depict various emotions for boys and girls respectively. Each card consists of a series of six figures depicting sequentially various emotions from 'happy' to 'unhappy and running away' of the cartoon character. Score 1 is happy face, score 2 is sad face, score 3 is crying face, score 4 is angry face, score 5 is shouting and score 6 is running. So, here, score 1 depicts patient is happy whereas as score increases anxiety level also increases which denotes that patient is unhappy.
1 secondary outcome
Behavior rating by using Frankel Behaviour rating scale
Time frame: after 10 minutes
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 5 Oct 2018.
- Individual participant dataSharing planned: Undecided. it will be dependent on publication
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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.
Sneha D Suwarnkar, MDS principal investigator
Saraswati Dhanwantari Dental College and Hospital, Parbhani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Syringe and Camouflage Syringe in people with Dental Anxiety and Behavior, run by Sneha D. Suwarnkar at 1 site in India.
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 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 5 Oct 2018. 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 India. 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?
Anxiety levels by using the Chotta Bheem and Chutki scale (time frame: after 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2018.