Trial Outcomes & Findings for Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia (NCT NCT06606587)
NCT ID: NCT06606587
Last Updated: 2026-04-30
Results Overview
Pain 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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Immediately after the anesthesia is administered
Results posted on
2026-04-30
Participant Flow
Participant milestones
| Measure |
Group Experimental: Application of Comfort-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. 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.
Comfort-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.
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Group Control: Application of Traditional Dental Injection Method
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.
Traditional Dental Injection: Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.
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|---|---|---|
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Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia
Baseline characteristics by cohort
| Measure |
Group Experimental: Application of Comfort-in Jet Injection Method
n=25 Participants
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.
Comfort-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.
|
Group Control: Application of Traditional Dental Injection Method
n=25 Participants
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.
Traditional Dental Injection: Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
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Sex: Female, Male
Male
|
13 Participants
n=14 Participants
|
10 Participants
n=34 Participants
|
23 Participants
n=69 Participants
|
|
Age, Categorical
<=18 years
|
25 Participants
n=14 Participants
|
25 Participants
n=34 Participants
|
50 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Continuous
|
10.84 years
STANDARD_DEVIATION 2.64 • n=14 Participants
|
10.72 years
STANDARD_DEVIATION 2.11 • n=34 Participants
|
10.78 years
STANDARD_DEVIATION 2.40 • n=69 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=14 Participants
|
15 Participants
n=34 Participants
|
27 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=14 Participants
|
25 Participants
n=34 Participants
|
50 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
Turkey
|
25 participants
n=14 Participants
|
25 participants
n=34 Participants
|
50 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: Immediately after the anesthesia is administeredPopulation: All participants who met the inclusion criteria, received the assigned anesthesia method, and completed the pain assessment procedure were included in the analysis. No participants were excluded after allocation.
Pain 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.
Outcome measures
| Measure |
Group Experimental: Application of Comfort-in Jet Injection Method
n=25 Participants
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.
Comfort-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.
|
Group Control: Application of Traditional Dental Injection Method
n=25 Participants
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.
Traditional Dental Injection: Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.
|
|---|---|---|
|
Pain Perception Measured by the Wong-Baker FACES Pain Rating Scale
|
1.04 score on a scale
Standard Deviation 1.54
|
4.24 score on a scale
Standard Deviation 2.85
|
PRIMARY outcome
Timeframe: During the administration of the palatal anesthesia injection.Population: All participants who completed the anesthesia procedure and for whom FLACC behavioral pain scores were recorded were included in the analysis.
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.
Outcome measures
| Measure |
Group Experimental: Application of Comfort-in Jet Injection Method
n=25 Participants
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.
Comfort-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.
|
Group Control: Application of Traditional Dental Injection Method
n=25 Participants
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.
Traditional Dental Injection: Application of Traditional Dental Injection Method: Traditional Dental Injection method was used for palatal anesthesia of the permanent 1st molar.
|
|---|---|---|
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Pain Perception Measured by the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale
|
1.28 score on a scale
Standard Deviation 0.54
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1.64 score on a scale
Standard Deviation 0.95
|
Adverse Events
Group Experimental: Application of Comfort-in Jet Injection Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Control: Application of Traditional Dental Injection Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Büşra Almas
Necmettin Erbakan University, Faculty of Dentistry, Department of Pediatric Dentistry
Phone: +905445598508
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place