Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Starpen automatic injection device, conventional syringe.
- Who it may be relevant to
- Registry conditions: Pain Perception of the New Device. Basic parameters: 6 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Computer Controlled Starpen Automatic Injection Device Versus Conventional Syringe on Pain Perception During Infiltration Anesthesia and Extraction of Maxillary Primary Molars : A Randomized Clinical Trial
Overview
To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.
Detailed description
After enrollment of the patients according to the eligibility criteria, taking full medical , dental history and informed consents from the parents. Clinical and radiographic examination will be done for the tooth to be extracted. A diagnostic chart with personal, medical and dental history will be filled out . Also preoperative psychological management of the child through positive reinforcement techniques should be done . Then the two parallel groups will have local anesthesia using an infiltration technique in the upper jaw ; one group with conventional syringe and the other group by Starpen automatic injection device . Both groups will have the site of injection well prepared before injection by the same way and technique. In Addition, procedures as anesthesia injection and extraction will be done according to the guidelines set by the American Academy of Pediatric Dentistry . After the procedure is done , the participants and their parents will be instructed about post-operative care and the need of a space maintainer will be taken into account. Moreover subjective and objective pain will be assessed and scored during procedure of anesthesia injection and extraction.
Interventions
- Device Starpen automatic injection device
Starpen device will be used on high speed 45-150s with the conventional carpule of articaine HCL 4% with 1:100,000 epinephrine and short needle - Procedure conventional syringe
injection will be done using conventional metal syringe with articaine HCL 4% with 1:100,000 epinephrine and short needle
Primary outcome measures
- Subjective pain during injection [Time frame: during procedure]
Secondary outcome measures (5)
- Objective pain during infiltration [Time frame: during procedure]
- Subjective pain during extraction [Time frame: during procedure]
- Objective pain during extraction [Time frame: during procedure]
- Physiological parameters ( heart rate ) [Time frame: Readings will be taken before and during anesthesia injection and during extraction.]
- Physiological parameter ( oxygen saturation) [Time frame: Readings will be taken before and during anesthesia injection and during extraction.]
Eligibility criteria
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 mentally capable of communication
- First dental visit
- Patient requiring extraction of upper primary molars due to root caries , crown fractures, periapical disease and failed pulpotomies
- No acute dental pain
Exclusion criteria
- Children with a behavioral management problem
- Parental refusal of participation
- Children with 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 the root
- Acute dental pain
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07156032 · SPen device injection in MPM