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

Cairo University (CU)

Status

Not yet enrolling

Conditions

Pain Perception of the New Device

Treatments

Procedure: conventional syringe

Device: Starpen automatic injection device

Study type

Interventional

Funder types

Other

Identifiers

NCT07156032

SPen device injection in MPM

Details and patient eligibility

About

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

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

6 to 8 years old

Volunteers

No Healthy Volunteers

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