Child BehaviourNCT06448507
Comparison of a Needle-free Local Anesthetic Technique With Traditional Syringe [ Needle Syringe] Technique for the Restoration of Primary Molars and Permanent Molars
A study testing INJEX [Needle less anesthesia] and Syringe Needle [ Traditional technique] in people with Child Behaviour, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system [Traditional syringe system] for restoration of Primary and young permanent teeth. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Child Behaviour
- What is being tested?
- INJEX [Needle less anesthesia] and Syringe Needle [ Traditional technique]
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Jan 2024to 30 Apr 2024
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 - 14 years
- Existence of deep carious Primary and Permanent molar, indicated for Indirect pup capping.
- Complete physical and mental health without any confounding medical history
- Parents who gave written informed consent
Who cannot join
- Children below 7 years of age
- Children complaining of irreversible pulpitis.
- Children with Negative behaviour according to the wright's modification of Frankl
- Behaviour Rating scale (FBRS) during initial examination
- Children with medical or mentally compromised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Needle-free Local Anesthetic Technique Compared to the Traditional Syringe Technique for the Restoration of Primary Molars and Young Permanent Molars: A Single-blind Randomized Clinical Trial
The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system [Traditional syringe system] for restoration of Primary and young permanent teeth. The main questions it aims to answer are:
- To evaluate pain perception for restoration of primary and young permanent tooth with a needle free system in a pediatric population.
- To evaluate pain perception for restoration of primary and young permanent tooth with needle syringe [Traditional syringe system] method in a pediatric population
- Time required to deliver anesthesia using needle free system vs Needle syringe [ traditional syringe system]
Participants who enrolled in the study will be anesthetized according to the respective groups i,e needle free system and traditional dental needle system and restoration will be done.
Read the detailed description
Before the start of the study a written informed consent and ascent was obtained from each parent of the children included in the study stating they accepted the treatment. Ethical clearance will be obtained before the start of the study. Patients reporting to the dental clinics, college of dentistry will be included in the study.
Sample size estimation:
the sample size was estimated to be twenty-one (21). Twenty percent of the estimated sample size was added to compensate for sampling loss if any, thus the final sample size accounted to a total of twenty-five (25) participants in each group.
study design: It was a single blinded randomized controlled trial
Randomization:
Children will be allocated into one of the following two groups using a simple randomization method with a random number table, employing the sequentially numbered opaque sealed envelopes method of allocation concealment.
Group I: All participants in this group were subjected to the traditional needle syringe system. Local infiltration of Scandicaine 2% Speciale [Mepivacaine Hydrochloride and adrenaline] was administered using a traditional needle syringe equipped with a 27-gauge needle.
Group II: Participants in this group received the needle-free injection system, specifically the INJEX (Injex Pharma AG, Germany) 0.3ml of 2% Scandicaine will be adminsitered.
Intervention procedure
To avoid any operator-related bias, a single operator will manage the entire anesthesia protocol for all participants in the trial. Employing the "tell-show-do" technique, all relevant treatment equipment and protocols were introduced and explained to the participants. The injection process was fully described using appropriate euphemisms. Before administering the injection, the treatment area at the injection site was cleansed using a sterile dry gauze, and a small amount of topical anesthetic (Benzocaine 20%, NJ, USA) was applied, remaining in place for at least one minute. Following the application of topical anesthesia, local anesthesia was administered based on the participant's assigned group. After a standard waiting period of three minutes for the onset of anesthesia, dental caries was removed, dycal applied and final restoration with composite was done.
- Conditions
- Child Behaviour
- Being tested
- INJEX [Needle less anesthesia], Syringe Needle [ Traditional technique]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INJEX [Needle less anesthesia]Device
already described
Syringe Needle [ Traditional technique]Device
described
| Study group | Role | What they receive |
|---|---|---|
| INJEX | Experimental | needle less device Receives: Device: INJEX [Needle less anesthesia] |
| Needle syringe | Active comparator | traditional dental needle Receives: Device: Syringe Needle [ Traditional technique] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children
FLACC assessment. FLACC gives an observational pain scale during the delivery of anesthesia
Measured: during and immediately after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Wong Baker Scale. Used to self-assess and effectively communicate the severity of pain they may be experiencing
Measured: During and immediately after the delivery of anesthesia
Secondary outcomes (3)
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
FBRS
Measured: before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Pulse rate
Measured: Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
time of local anesthesia administration
Measured: during the delivery of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start16 Jan 2024
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviourStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, satish vishwanathaiah, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448507
- Sponsor's protocol ID
- Jazan University
- Status last verified
- Aug 2024
- First submitted
- 17 May 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Needle-free Local Anesthetic Technique Compared to the Traditional Syringe Technique for the Restoration of Primary Molars and Young Permanent Molars: A Single-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06448507
- Acronym / sponsor ID
- Jazan University
- Conditions
- Child Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Jun 2024 (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.
The goal of this clinical trial is to compare the effectiveness of needle free system and dental needle system [Traditional syringe system] for restoration of Primary and young permanent teeth. The main questions it aims to answer are:
- To evaluate pain perception for restoration of primary and young permanent tooth with a needle free system in a pediatric population.
- To evaluate pain perception for restoration of primary and young permanent tooth with needle syringe [Traditional syringe system] method in a pediatric population
- Time required to deliver anesthesia using needle free system vs Needle syringe [ traditional syringe system]
Participants who enrolled in the study will be anesthetized according to the respective groups i,e needle free system and traditional dental needle system and restoration will be done.
Detailed description
Before the start of the study a written informed consent and ascent was obtained from each parent of the children included in the study stating they accepted the treatment. Ethical clearance will be obtained before the start of the study. Patients reporting to the dental clinics, college of dentistry will be included in the study.
Sample size estimation:
the sample size was estimated to be twenty-one (21). Twenty percent of the estimated sample size was added to compensate for sampling loss if any, thus the final sample size accounted to a total of twenty-five (25) participants in each group.
study design: It was a single blinded randomized controlled trial
Randomization:
Children will be allocated into one of the following two groups using a simple randomization method with a random number table, employing the sequentially numbered opaque sealed envelopes method of allocation concealment.
Group I: All participants in this group were subjected to the traditional needle syringe system. Local infiltration of Scandicaine 2% Speciale [Mepivacaine Hydrochloride and adrenaline] was administered using a traditional needle syringe equipped with a 27-gauge needle.
Group II: Participants in this group received the needle-free injection system, specifically the INJEX (Injex Pharma AG, Germany) 0.3ml of 2% Scandicaine will be adminsitered.
Intervention procedure
To avoid any operator-related bias, a single operator will manage the entire anesthesia protocol for all participants in the trial. Employing the "tell-show-do" technique, all relevant treatment equipment and protocols were introduced and explained to the participants. The injection process was fully described using appropriate euphemisms. Before administering the injection, the treatment area at the injection site was cleansed using a sterile dry gauze, and a small amount of topical anesthetic (Benzocaine 20%, NJ, USA) was applied, remaining in place for at least one minute. Following the application of topical anesthesia, local anesthesia was administered based on the participant's assigned group. After a standard waiting period of three minutes for the onset of anesthesia, dental caries was removed, dycal applied and final restoration with composite was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INJEX | Experimental | Device: INJEX [Needle less anesthesia]needle less device |
| Needle syringe | Active comparator | Device: Syringe Needle [ Traditional technique]traditional dental needle |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 7 - 14 years
- Existence of deep carious Primary and Permanent molar, indicated for Indirect pup capping.
- Complete physical and mental health without any confounding medical history
- Parents who gave written informed consent
Key exclusion criteria (5 listed)
- Children below 7 years of age
- Children complaining of irreversible pulpitis.
- Children with Negative behaviour according to the wright's modification of Frankl
- Behaviour Rating scale (FBRS) during initial examination
- Children with medical or mentally compromised
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 |
|---|---|---|
| INJEX [Needle less anesthesia]already described | Device | INJEX |
| Syringe Needle [ Traditional technique]described | Device | Needle syringe |
Primary outcome
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children
Time frame: during and immediately after the delivery of anesthesia
FLACC assessment. FLACC gives an observational pain scale during the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time frame: During and immediately after the delivery of anesthesia
Wong Baker Scale. Used to self-assess and effectively communicate the severity of pain they may be experiencing
3 secondary outcomes
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time frame: before the delivery of anesthesia, during the delivery of anesthesia and after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time frame: Before the delivery of anesthesia, immediately after the delivery of anesthesia, and 1 minute after the delivery of anesthesia
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/needle syringe in children
Time frame: during the delivery of anesthesia
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 29 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INJEX [Needle less anesthesia] and Syringe Needle [ Traditional technique] in people with Child Behaviour, run by University of Jazan at 1 site in Saudi Arabia.
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: finished, as of the sponsor's last update on 29 Aug 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 Saudi Arabia. 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?
Comfort and Patient acceptance of the needle less anesthesia technique and traditional/ syringe needle in children (time frame: during and immediately after the delivery of anesthesia). The study lists 2 primary outcomes in all. 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 29 Aug 2024.