Dental AnxietyNCT03033628
Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children
A study testing injection using DentalVibe comfort system and traditional dental injection in people with Dental Anxiety, run by Cairo University.
Trial summary
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- injection using DentalVibe comfort system and traditional dental injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to 1 Jan 2018
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 6-7 years old.
- Apparently healthy Children.
- Cooperative children.
- Children with carious maxillary bilateral primary molars indicated for extraction.
Who cannot join
- Children who are allergic to amide group.
- Children with Neurologic disorders.
- Children with mental disability.
- Presence of periapical or gingival legion.
- Severe Gingivitis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using "DentalVibe Comfort System" Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.
Read the detailed description
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone.
Intervention:
History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria.
Clinical procedure:
Intervention group:
Clinical examination using mirror and probe to assess inclusion criteria. Before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec.
Demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally.
The cheek will be retracted and the device will be turned on.
1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min.
Control group:
AS that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off.
Assessment:
Objective assessment will be performed by observing the patients behavior using the FLAAC scale during the anesthetic injection and needle insertion.
Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.
- Conditions
- Dental Anxiety
- Being tested
- injection using DentalVibe comfort system, traditional dental injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection using DentalVibe comfort systemDevice
giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
traditional dental injectionDevice
giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
| Study group | Role | What they receive |
|---|---|---|
| DV group | Experimental | Device: injection using DentalVibe comfort system. giving maxillary infiltration dental local anesthesia with the aid of "DentalVibe comfort system" on one side of the maxillary arch prior extraction of primary molar tooth Receives: Device: injection using DentalVibe comfort system |
| C group | Active comparator | Device: traditional dental injection giving maxillary infiltration dental local anesthesia without the aid of "DentalVibe comfort system" on the other side of the maxillary arch prior extraction of primary molar tooth Receives: Device: traditional dental injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during injection
pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.
Measured: within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Apr 2017 (estimated)
- Primary completion1 Jun 2017 (estimated)
- Study completion1 Jan 2018 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muaaz Marwan halal, Cairo University
- Investigators
- Norhan El-dokky, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033628
- Sponsor's protocol ID
- CEBC-CU-2017-01-06
- Status last verified
- Feb 2017
- First submitted
- 22 Jan 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using "DentalVibe Comfort System" Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03033628
- Acronym / sponsor ID
- CEBC-CU-2017-01-06
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 1 Jan 2018 (estimated)
- First posted
- 27 Jan 2017 (estimated)
- 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.
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.
Detailed description
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone.
Intervention:
History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria.
Clinical procedure:
Intervention group:
Clinical examination using mirror and probe to assess inclusion criteria. Before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec.
Demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally.
The cheek will be retracted and the device will be turned on.
1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min.
Control group:
AS that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off.
Assessment:
Objective assessment will be performed by observing the patients behavior using the FLAAC scale during the anesthetic injection and needle insertion.
Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DV group | Experimental | Device: injection using DentalVibe comfort systemDevice: injection using DentalVibe comfort system. giving maxillary infiltration dental local anesthesia with the aid of "DentalVibe comfort system" on one side of the maxillary arch prior extraction of primary molar tooth |
| C group | Active comparator | Device: traditional dental injectionDevice: traditional dental injection giving maxillary infiltration dental local anesthesia without the aid of "DentalVibe comfort system" on the other side of the maxillary arch prior extraction of primary molar tooth |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 6-7 years old.
- Apparently healthy Children.
- Cooperative children.
- Children with carious maxillary bilateral primary molars indicated for extraction.
Key exclusion criteria (5 listed)
- Children who are allergic to amide group.
- Children with Neurologic disorders.
- Children with mental disability.
- Presence of periapical or gingival legion.
- Severe Gingivitis.
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 |
|---|---|---|
| injection using DentalVibe comfort systemgiving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system. | Device | DV group |
| traditional dental injectiongiving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system. | Device | C group |
Primary outcome
pain during injection
Time frame: within 1 year
pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- 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.
Norhan El-dokky, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing injection using DentalVibe comfort system and traditional dental injection in people with Dental Anxiety, run by Cairo University.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muaaz Hilal, DR (00201226090374, muaaz09@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during injection (time frame: within 1 year). 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 15 Feb 2017.