Effect of Starpen CCLAD in Injection and Extraction (Starpen CCLAD)

February 10, 2025 updated by: Sara Mostafa Abohashim Masoud Soliman, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children aged 6-8 years
  • Cooperative children (Rating 3 or 4 based on the Frankl behavior scale)
  • Medically fit children (ASA I).
  • Children are mentally capable of communication.
  • First dental visit.
  • Patient requiring extraction of lower primary molars due to root caries, crown fractures, periapical disease, and failed pulpotomies.

Exclusion Criteria:

  • Children with a behavioral management problem.
  • Parental refusal of participation.
  • Children with a previous history of local anesthesia injection.
  • Medically unfit children (other than ASA I).
  • Uncooperative children (other than Frankl 3,4).
  • Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
  • Teeth that showed any signs of mobility, ankylosis, or root resorption affecting more than one-third of the root

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
nerve block anesthesia and extraction of mandibular primary molars using a Traditional Syringe
Device: Traditional Syringe
nerve block anesthesia and extraction of mandibular primary molars using Traditional Syringe
Experimental: intervention group
nerve block anesthesia and extraction of mandibular primary molars using Computer-controlled Starpen Automatic Injection Device
Device: computer-controlled Starpen Automatic Injection Device
using computer-controlled Starpen Automatic Injection Device during inferior alveolar nerve block anesthesia and extraction of mandibular primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Pain perception during injection of local anesthesia
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"
immediately after the procedure(injection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective pain perception during local anesthesia injection
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"
During the procedure (injection)
Subjective pain perception during the extraction
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"
immediately after the procedure(extraction)
objective pain perception during extraction
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"
During the procedure (extraction)
Physiological parameter (heart rate)
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
at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)
Physiological parameter (oxygen saturation)
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
at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Starpen CCLAD in injection

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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