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Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia

Evaluation of the Effectiveness of the Comfort-In Needle-Free Injector System During Palatal Infiltrative Anesthesia in Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06606587
Enrollment
50
Registered
2024-09-23
Start date
2023-01-01
Completion date
2023-12-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetics, Physiological Effects of Drugs

Keywords

Comfort-In, Dental anxiety, Needle-free injection, Palatal infiltrative anesthesia

Brief summary

The goal of this randomized clinical trial is to compare two different injection methods in children. The main question it aims to answer is: Is the needle-free injection method more painless than the traditional dental method? Two different methods will be used for children to perform anesthesia for extraction permanent molars.

Detailed description

Study Groups and Study Design: 50 volunteer children between the ages of 6-15 who applied to Faculty of Dentistry Department of Pedodontics clinic with their parents were included in our study. Volunteer children with an indication for maxillary permanent first molar tooth extraction were randomly divided into two groups and included in the study. For randomization, methods were written on two different envelopes and the child was allowed to choose the envelope. The child was assigned to the selected method. Group Control: Application of Traditional Dental Injection Method Palatal injection; It was applied 5-10 mm below the palatal gingival margin\*, on the attached gum, and with a 45-degree needle angle. After needle entry, 0.2-0.3 mL of anesthetic solution was stored when bone contact was removed (3-5 mm). 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine and a 27 G dental needle were used as local anesthetic agents for injections. 25 patients were included in this group and the procedure was performed. After waiting for 5 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed. Group Experimental: Application of Comfort-in Jet Injection Method Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar. Using a silicone flat cap, it was placed 5 mm below the palatal gingival margin, close to the free gingiva, and with a steep angle. 0.3 ml of anesthetic solution was administered by pressing the jet injection system button. 1 mL Articaine Hydrochloride (Ultracaine D-S forte, Hoechst, Canada) containing 1/100,000 epinephrine was used as a local anesthetic agent in the injections. 25 patients were included in this group and the procedure was performed. After waiting for 2 minutes, the anesthetized area was probed with the help of a probe (probing gingiva) to check whether the anesthesia had taken effect. Afterwards, buccal infiltration anesthesia was performed with the help of a traditional dental injector and tooth extraction was performed.

Interventions

DEVICEComfort-in Jet Injection Method

Application of Comfort-in Jet Injection Method: Comfort-in jet injection method was used for palatal anesthesia of the permanent 1st molar.

Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

When giving data to the statistician, he will not be told which group the data is in. The data will be changed to a and b to try to prevent bias.

Intervention model description

Participants meeting the inclusion criteria were randomly assigned to one of two groups. To ensure randomization, two sealed envelopes, each containing one of the anesthesia methods, were prepared. One envelope contained "Group 1" and the other contained "Group 2". Each participant selected an envelope, determining their assigned anesthesia technique. In Group 1, palatal anesthesia was administered using the Comfort-In™ jet injection system, while in Group 2, a dental needle injection was used.

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

Child patient between the ages of 6-16, Requiring extraction of maxillary permanent molars and premolars with bilateral palatal infiltration anesthesia, Showing "positive" and "definitely positive" behavior during examination according to the Frankl scale, Family volunteers, No medical or developmental disease

Exclusion criteria

If there are medical or developmental disorders, If there is a chronic disease, If there is an allergy to anesthetic solutions, If there is any pathology in the anesthesia area, If the Frankl scale is "negative" and "definitely negative", If the mouth opening is not sufficient, If there is no need for symmetrical treatment in the teeth

Design outcomes

Primary

MeasureTime frameDescription
Pain Perception Measured by the Wong-Baker FACES Pain Rating ScaleImmediately after the anesthesia is administeredPain perception was assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain intensity.
Pain Perception Measured by the Face, Legs, Activity, Cry, and Consolability (FLACC) ScaleDuring the administration of the palatal anesthesia injection.Pain perception was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the highest level of pain. Higher scores indicate worse outcomes (greater pain intensity). Behavioral responses during the injection were video-recorded and later evaluated.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIRHalenur Altan

Necmetttin Erbakan University Dentistry Faculty

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
25 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous10.84 years
STANDARD_DEVIATION 2.64
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
50 Participants
Region of Enrollment
Turkey
25 participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 25
other
Total, other adverse events
0 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026