Early Childhood CariesNCT05959642
Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes
A study testing dentapen and Traditional metal Syringes in people with Early Childhood Caries, run by Cairo University.
Trial summary
This study compares the effect of the controlled flow delivery Dentapen® technique to traditional syringes on pain perception during dental procedures among a group of pediatric dental patients Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- dentapen and Traditional metal Syringes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Dec 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 6 and 8 years
- Healthy children with no systemic problems.
- Cooperative Children
- First dental visit
- Children willing to provide assent and parent willing to provide informed consent
- Bilaterally decayed primary maxillary first molars with normal radiographic findings and need restorative treatment
Who cannot join
- Children with previously restored teeth
- Children requiring emergency dental treatment (cellulitis, abscess)
- Children's teeth with signs or symptoms of Pulpitis
- Children whose parents refuse to sign the informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes on Pain Perception During the Administration of Anesthesia Among A Group of Pediatric Dental Patients: A Split-Mouth Randomized Clinical Trial
This study compares the effect of the controlled flow delivery Dentapen® technique to traditional syringes on pain perception during dental procedures among a group of pediatric dental patients
Read the detailed description
Local anesthetic injections are usually the main reason for fear and anxiety during dental treatment. Pain management is a critical aspect of pediatric dental care. Fear associated with seeing and experiencing needle penetration, sensation of swelling soft tissues and prolonged numbness as well as allergic reactions to the anesthetic fluid, are the most common factors causing patients and dental clinicians to experience anxiety regarding the use of infiltration local anesthesia. Exploring new alternative and a traumatic method will help improving the quality of care in pediatric dentistry.
Consequently, there is a constant search for new techniques looking to avoid the invasive and often painful nature of the anaesthetic injection required for dental treatments, making it a more pleasant and less distressing experience for patients.
Even though there are no techniques available that can totally replace conventional local anaesthesia, some alternatives have been developed that are effective in a limited range of procedures. In 1997, a new method for the administration of anaesthetics was launched: the computer- controlled local anaesthesia delivery system (CCLADS). After
2006, the single tooth anaesthesia system (STA) (Milestone Scientific, Inc. Livingston, NJ, USA) was also introduced.
Currently, one of the most discouraging aspects for many patients undergoing dental procedures is the administration of anaesthesia. Consequently, there is a constant search for new techniques to avoid the invasive and painful nature of the injection. A new, cableless, motorised syringe system (Dentapen®) has recently been developed, standing out for its convenience and ease of use. The slow injection of anaesthetics at low pressure appears to reduce pain and discomfort during dental anaesthesia, and that currently does not require specific training. It has several injection settings, allowing it to be held like a syringe or pen, and is compatible with all anaesthetic needles and cartridges from all brands with an accurate control of flow and pressure of the injection can therefore mitigate the pain experienced by these patients.
So, the purpose of the current study was to evaluate the effect of controlled flow delivery Dentapen® technique on pain perception among a group of pediatric dental patients in comparison to conventional injection technique.
- Conditions
- Early Childhood Caries
- Being tested
- dentapen, Traditional metal Syringes
- Keywords
- non invasive technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dentapenDevice
Experimental: Controlled Flow Delivery Dentapen according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted upper D teeth.
Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle
Traditional metal SyringesDevice
Active Comparator: Conventional Injection of infiltration upper d a standard technique for the Injection of infiltration upper d will be used supplemented with long buccal infiltration for the buccal gingiva.
A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed to primary molars
| Study group | Role | What they receive |
|---|---|---|
| Controlled Flow Delivery Dentapen | Experimental | Controlled Flow Delivery Dentapen - infiltration upper d according to the manufacturer instructions it works with standardised 1.8 ml local anaesthetic carpules . 1)we raise the lip a little 2) we use dentapen for anaesthesia 3) class 1 cavity preparation Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected.The dentist will wait 5 seconds Receives: Device: dentapen |
| Traditional metal Syringes | Active comparator | Traditional metal Syringes we raise the lip a little 2) infiltration upper d we use traditional syringes 3)class 1 cavity preparation with composit filling works with standardised 1.8 ml local anaesthetic carpules . we use Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected.The dentist will wait 5 seconds Receives: Device: Traditional metal Syringes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception during injection of local anesthesia
Wong-Baker faces pain rating scale; Scores (0-10)
Measured: in the same visit after finishing the procedure, 0 scale - no pain , 10 scale -worest
Secondary outcomes (1)
Heart rate during injection of local anesthesia
measured by Pulse oximeter, Beats per minute (BPM)
Measured: in the same visit after finishing the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
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 Early Childhood CariesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, reham salman alshakhs, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959642
- Sponsor's protocol ID
- Denta pen
- Status last verified
- Jul 2023
- First submitted
- 17 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvajal-Nunez U, Prieur D, Vitova T, Somers J. Charge distribution and local structure of americium-bearing thorium oxide solid solutions. Inorg Chem. 2012 Nov 5;51(21):11762-8. doi: 10.1021/ic301709d. Epub 2012 Oct 16.
PubMed 23072315
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Controlled Flow Delivery Dentapen® Technique to Traditional Syringes on Pain Perception During the Administration of Anesthesia Among A Group of Pediatric Dental Patients: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05959642
- Acronym / sponsor ID
- Denta pen
- Conditions
- Early Childhood Caries
- Keywords
- non invasive technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Jul 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.
This study compares the effect of the controlled flow delivery Dentapen® technique to traditional syringes on pain perception during dental procedures among a group of pediatric dental patients
Detailed description
Local anesthetic injections are usually the main reason for fear and anxiety during dental treatment. Pain management is a critical aspect of pediatric dental care. Fear associated with seeing and experiencing needle penetration, sensation of swelling soft tissues and prolonged numbness as well as allergic reactions to the anesthetic fluid, are the most common factors causing patients and dental clinicians to experience anxiety regarding the use of infiltration local anesthesia. Exploring new alternative and a traumatic method will help improving the quality of care in pediatric dentistry.
Consequently, there is a constant search for new techniques looking to avoid the invasive and often painful nature of the anaesthetic injection required for dental treatments, making it a more pleasant and less distressing experience for patients.
Even though there are no techniques available that can totally replace conventional local anaesthesia, some alternatives have been developed that are effective in a limited range of procedures. In 1997, a new method for the administration of anaesthetics was launched: the computer- controlled local anaesthesia delivery system (CCLADS). After
2006, the single tooth anaesthesia system (STA) (Milestone Scientific, Inc. Livingston, NJ, USA) was also introduced.
Currently, one of the most discouraging aspects for many patients undergoing dental procedures is the administration of anaesthesia. Consequently, there is a constant search for new techniques to avoid the invasive and painful nature of the injection. A new, cableless, motorised syringe system (Dentapen®) has recently been developed, standing out for its convenience and ease of use. The slow injection of anaesthetics at low pressure appears to reduce pain and discomfort during dental anaesthesia, and that currently does not require specific training. It has several injection settings, allowing it to be held like a syringe or pen, and is compatible with all anaesthetic needles and cartridges from all brands with an accurate control of flow and pressure of the injection can therefore mitigate the pain experienced by these patients.
So, the purpose of the current study was to evaluate the effect of controlled flow delivery Dentapen® technique on pain perception among a group of pediatric dental patients in comparison to conventional injection technique.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled Flow Delivery Dentapen | Experimental | Device: dentapenControlled Flow Delivery Dentapen - infiltration upper d according to the manufacturer instructions it works with standardised 1.8 ml local anaesthetic carpules . 1)we raise the lip a little 2) we use dentapen for anaesthesia 3) class 1 cavity preparation Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected.The dentist will wait 5 seconds |
| Traditional metal Syringes | Active comparator | Device: Traditional metal SyringesTraditional metal Syringes we raise the lip a little 2) infiltration upper d we use traditional syringes 3)class 1 cavity preparation with composit filling works with standardised 1.8 ml local anaesthetic carpules . we use Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected.The dentist will wait 5 seconds |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged between 6 and 8 years
Key exclusion criteria (4 listed)
- Children with previously restored teeth
- Children requiring emergency dental treatment (cellulitis, abscess)
- Children's teeth with signs or symptoms of Pulpitis
- Children whose parents refuse to sign the informed consent.
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 |
|---|---|---|
| dentapenExperimental: Controlled Flow Delivery Dentapen according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted upper D teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle | Device | Controlled Flow Delivery Dentapen |
| Traditional metal SyringesActive Comparator: Conventional Injection of infiltration upper d a standard technique for the Injection of infiltration upper d will be used supplemented with long buccal infiltration for the buccal gingiva. A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed to primary molars | Device | Traditional metal Syringes |
Primary outcome
Pain perception during injection of local anesthesia
Time frame: in the same visit after finishing the procedure, 0 scale - no pain , 10 scale -worest
Wong-Baker faces pain rating scale; Scores (0-10)
1 secondary outcome
Heart rate during injection of local anesthesia
Time frame: in the same visit after finishing the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 23072315Carvajal-Nunez U, Prieur D, Vitova T, Somers J. Charge distribution and local structure of americium-bearing thorium oxide solid solutions. Inorg Chem. 2012 Nov 5;51(21):11762-8. doi: 10.1021/ic301709d. Epub 2012 Oct 16.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing dentapen and Traditional metal Syringes in people with Early Childhood Caries, 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 6 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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 Reham Salman Alshakhs (00966599928825 ext. 0, rehamsalman23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception during injection of local anesthesia (time frame: in the same visit after finishing the procedure, 0 scale - no pain , 10 scale -worest). 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 NCT05959642, 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 27 Jul 2023.