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NCT Number: NCT07156032

Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars

To evaluate the effect of Starpen device on pain perception during anesthesia and extraction of maxillary primary molars.

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Key information

Conditions

Pain Perception of the New Device

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Starpen automatic injection device

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

Other names: computer controlled injection device

conventional syringe

Procedure

injection will be done using conventional metal syringe with articaine HCL 4% with 1:100,000 epinephrine and short needle

Other names: dental syringe

Primary outcomes

  1. Subjective pain during injection

    Time frame: during procedure

    Subjective pain perception during injection of infiltration anesthesia using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.

Secondary outcomes

  1. Objective pain during infiltration

    Time frame: during procedure

    Objective pain perception during infiltration anesthesia using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain.

  2. Subjective pain during extraction

    Time frame: during procedure

    Subjective pain perception during extraction of maxillary primary molars using Wong Baker Scale which represents a series of faces from 0-value happy face that represents lack of pain to a 10-value crying face which represents the worst possible face . On this basis , the patient chooses the face that best describes his/her level of pain.

  3. Objective pain during extraction

    Time frame: during procedure

    Objective pain perception during extraction of maxillary primary molars using Faces, legs, Arms, Crying, Consolability (FLACC) scale . The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0 = relaxed and comfortable, 1-3=mild, 4-6=moderate pain, 7-10=severe discomfort/ pain.

  4. Physiological parameters ( heart rate )

    Time frame: Readings will be taken before and during anesthesia injection and during extraction.

    Physiological parameters ( heart rate) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 70-100 bpm is the normal range at rest and higher heart rate readings reflects anxiety/pain/ discomfort .

  5. Physiological parameter ( oxygen saturation)

    Time frame: Readings will be taken before and during anesthesia injection and during extraction.

    Physiological parameter ( oxygen saturation) at three time points : baseline , during injection and during extraction using pulse oximeter on the child's index finger. At which 95-100% is the normal range on room air . A drop below 94% indicates hypoxemia and immediate assessment must be for airway and breathing.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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