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

N/ANot Yet RecruitingNCT07156032

Cairo University38 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Perception of the New Device

Interventions

Starpen automatic injection deviceDEVICE

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

conventional syringePROCEDURE

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 8 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Subjective pain during injection

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.

Time frame: during procedure

Secondary Outcomes

Objective pain during infiltration

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.

Time frame: during procedure

Subjective pain during extraction

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.

Time frame: during procedure

Objective pain during extraction

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.

Time frame: during procedure

Physiological parameters ( heart rate )

Data from ClinicalTrials.gov

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