Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars

NCT06001710 | Completed

• 1 other identifier: Jet injector anesthesia
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the efficiency of needleless jet injection versus traditional inferior alveolar nerve block anesthesia in management of pain and anxiety during vital pulpotomy of lower second primary molars using Wong-Baker FACES Pain Rating Scale and Venham's anxiety and behavioral rating scale..

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (2)

• Wong-Baker FACES Pain Rating Scale

  a method for someone to self-assess and effectively communicate the severity of pain they may be experiencing. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts"

  After local anesthesia and during pulpotomy

• Venham's anxiety and behavioral rating scale

  assess the anxiety and uncooperative behavior of children in the dental setting.consist of five behavioral defined categories ranging from 0 to 5 with higher score, indicating greater level of anxiety or lack of cooperation.

  After local anesthesia and during pulpotomy

Study Arms (2)

classic inferior alveolar nerve block anesthesia

ACTIVE COMPARATOR

Inferior alveolar nerve block (IANB) is a technique of dental anesthesia, used to produce anesthesia of the mandibular teeth, gingivae of the mandible and lower lip. The conventional IANB is the most commonly used the nerve block technique for achieving local anesthesia for mandibular surgical procedures using long needle

Device: Needleless jet injector

needleless jet injector anesthesia

EXPERIMENTAL

Jet injection technology uses mechanical energy to force a liquid drug into subcutaneous tissues without a needle using infiltration technique

Device: Needleless jet injector

Interventions

Needleless jet injector DEVICE

Device consist of injection pen, ampule and activator.

classic inferior alveolar nerve block anesthesia; needleless jet injector anesthesia

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Apparently healthy children.
• Children aged from 4-8 years old.
• Both boys and girls were included
• Children scored (2 or 3) Frankle behavior rating scale.
• Children had bilateral deep carious lower second primary molars indicated clinically and radiographically for vital pulpotomy
• Informed consent was included from parents or caregivers.

You may not qualify if:

• Children with evidence of allergy to any materials used in this study
• Clinical criteria:
• Clinical history of spontaneous pain, intra-oral facial swelling or presence of fistula or sinus tract.
• Tooth with irreversible pulpitis, determined as continuous bleeding exceeding 5 minutes, dark to purple blood color or pulp necrosis.
• Radiographic criteria:
• Presence of any signs of internal or external root resorption, furcation radiolucency or periapical pathosis as revealed by preoperative periapical radiography.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of medicine , Suez Canal University

Ismailia, 41522, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

EG (1)