computer-controlled Starpen Automatic Injection Device
Deviceusing computer-controlled Starpen Automatic Injection Device during inferior alveolar nerve block anesthesia and extraction of mandibular primary molars
NCT Number: NCT06827223
The present study aims to evaluate the effect of computer-controlled Starpen automatic injection device versus the traditional syringe on pain perception during Injection of nerve block anesthesia and extraction of mandibular primary molars.
Trial opening soon.
Get Notified6 year–8 year
All sexes
Interventional
Not applicable
Pain is "An unpleasant sensory and emotional experience connected to actual or potential tissue damage or described in terms of such damage". According to the American Academy of Pediatric Dentistry, a patient may experience serious physical and psychological complications from improper pain management.
Anxiety, a fear of dental procedures, is often linked to unpleasant stimuli such as needle phobia, high vibration, noises, pain, and the smell of materials or medications. Patients who experience anxiety often exhibit complex behavior before or during dental procedures, causing additional discomfort.
In most dental procedures, Local anesthetic (LA) is crucial to alleviate pain during dental procedures enabling the dentist to complete the process. Even though LA is used to reduce pain during the procedure, but traditional methods itself can cause pain, making pediatric patients anxious and uncooperative in dental offices.
Effective pain management is crucial for children receiving dental injections to promote comfort, cooperation, and compliance. These techniques include topical analgesics, distraction, injection rates, buffering and warming the local anesthesia, speed reduction, fine needles, and precooling. Yet, no conclusive painless injection technique has been developed yet.
Finally, The Wand system, developed in 1997 by Milestone Scientific Inc., it was the first Computer-Controlled Local Anesthesia Delivery (CCLAD)discovered. Other devices like Morpheus, Calaject, Quicksleeper, and Smartject have entered the market, these systems varying in injection speed, design, weight, and shape, so, dentists can select the one that best meets their requirements.
This device's main concept is that a local anesthetic injection is done by lowering the pressure and flow rate.
The CCLAD reduced destructive behaviors in young children who were difficult to cooperate compared to the traditional method and created a positive experience for both the patient and physician.
The main advantage of these CCLADS devices is The ability to provide a small quantity of the local anesthetic solution with a stable injection mode, which decreases the discomfort associated with less controlled injections. In both adult and pediatric dentistry, the CCLADS devices have proven effective for extractions, pulpal therapies, and restorations. Patients also tolerate them well and behave less disruptively.
The Traditional injection syringe compared with computer-controlled local analgesic delivery devices (CCLAD) regarding disruptive behavior, pain, anxiety, and biochemical parameters. The results showed lower VAS, WBS, and salivary cortisol values in CCLADS patients compared to the traditional syringe group. They concluded that a positive impact of CCLADS on pain and anxiety can be recommended for pediatric patients.
Using CCLADs is significantly less painful than using traditional syringes and opens new, promising opportunities for working with patients presenting high dental fear.
The Starpen is one of the most recent advances that is promoted as a more comfortable and painless alternative to the traditional local anesthetic syringe. It includes a power adapter, cartridge holder, handpiece, and charging base. In dental uses, it can be injected intramuscularly or subcutaneously. It comes in three different speeds-high, low, and hybrid-and two aspiration modes-manual and auto. It may be used with the majority of the conventional gauge needles.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
using computer-controlled Starpen Automatic Injection Device during inferior alveolar nerve block anesthesia and extraction of mandibular primary molars
nerve block anesthesia and extraction of mandibular primary molars using Traditional Syringe
Time frame: immediately after the procedure(injection)
After injection, the child will be asked to choose a face from the Wong-Baker faces pain rating scale to express his pain experience after explaining the scale to him (Scores from 0 to 10),The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable . "the higher score means a worse outcome"
Time frame: During the procedure (injection)
During injection, the objective pain perception will be assisted by an external evaluator (the assistant supervisor), using the Faces, Legs, Activity, Cry, and Consolability scale with scores from (0 to 10) with score (0) represents that the patient is relaxed and comfortable and score (10) represents severe discomfort/pain "the higher score means a worse outcome"
Time frame: immediately after the procedure(extraction)
After extraction, the subjective pain perception will be recorded from the child by asking him to choose a face from the Wong-Baker faces pain rating scale to express his pain experience during the extraction after explaining the scale to him with scores from (0 to 10). The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable .
"the higher score means a worse outcome"
Time frame: During the procedure (extraction)
During extraction, the objective pain perception will be assisted by an external evaluator (the assistant supervisor), using the Faces, Legs, Activity, Cry, and Consolability scale with scores from (0 to 10) with score (0) represents that the patient is relaxed and comfortable and score (10) represents severe discomfort/pain "the higher score means a worse outcome"
Time frame: at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)
Physiological parameter (heart rate) with measuring unit(Beats per minute ) will be recorded at three-time points: baseline (10 minutes before the procedure), during injection, and extraction with a Pulse oximeter on the child's index finger
Time frame: at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)
Physiological parameter (oxygen saturation) with measuring unit(percent (%)) will be recorded at three-time points: baseline (10 minutes before the procedure), during injection, and extraction with a Pulse oximeter on the child's index finger
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Comparative Evaluation of the Effect of Computer-controlled Starpen Automatic Injection Device Versus Traditional Syringe on Pain Perception During Nerve Block Anesthesia and Extraction of Mandibular Primary Molars: a Randomized Controlled Trial
Acronym: Starpen CCLAD
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