- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03917121
Pain Control of Needle-free Versus Needle Injected Local Anesthesia for Pulpotomy of Upper Primary Molars in Children
July 23, 2019 updated by: Lobna Salah El-Dien Mohamed Ahmed, Cairo University
Pain Control of Needle-less Jet Anesthesia Versus Conventional Infiltration Anesthesia for Pulpotomy of Maxillary Primary Molars in Children: A Randomized Controlled Trial
This is a study that will be conducted on 6 to 8 years old children to compare the needle-less jet injector with the conventional needle attached syringe in terms of efficiency in controlling pain of local anesthetic infiltration and post-anesthetic pulpotomy of upper first primary molars.
The study tests a null hypothesis that states that there is no difference in pain control efficiency of the compared anesthetic techniques when used for the selected treatment procedure in the specified population.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
- The conduct of this study is driven by the substantial advantages that are documented to be offered by jet anesthesia over needle injected anesthesia combined with the scarcity, heterogeneity, limitations and contradicting inconclusive results of previously conducted studies assessing the acceptance and anesthetic efficiency of jet injectors against conventional needle attached dental syringes in pediatric patients, particularly for pulpotomy of primary molars. Jet injection offers the opportunity to deliver local anesthesia without using a needle and hence helps to avoid all drawbacks associated with needle injection such as psychological distress; pain; inability to cope with dental treatment; prolonged chair-side time; avoidance of dental care; high clinician skills required for child management and needle-stick injuries. It also allows precise controlled dosing; fast delivery and onset of local anesthesia; absence of post-operative numbness and thus self-inflicted traumatic injuries; reduction of medical waste and cutting down of long-term costs on the clinician. However, the true adequacy of jet anesthesia necessary to complete dental treatment successfully and the acceptance of jet injection in a child patient is yet to be revealed through further research.
- This randomized controlled trial is to be performed on children attending the Diagnosis outpatient clinic in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt. Children will be screened via personal, medical and dental history taking from them and their parents/caregivers; clinical examination and radiographic examination to identify appropriateness for recruitment in the trial based on the pre-specified eligibility criteria. Legal guardians of eligible children will be informed of the trial aims, conditions and procedures in details and a written informed consent will be obtained from them upon agreement for their children to participate in the trial. A verbal assent will be also obtained from each potential participant following a simple explanation of the trial procedure.
- Based on the sample size to be calculated, a random allocation sequence will be computer generated and will be used to assign participants to the experimental group receiving jet anesthesia (group A) and the control group receiving conventional infiltration anesthesia (group B). The allocation sequence will be enclosed in sequentially numbered, opaque, sealed envelopes and disclosure of the randomization code to the principle investigator will be performed only upon allocation of each corresponding subject throughout the course of the trial.
- For each study group, participants will be introduced to the dental setting and dental instruments to be used and have the anesthetization and dental procedure simply explained while avoiding any anxiety-provoking words. Psychological behavior management techniques such as Tell-Show-Do, voice control, distraction and positive reinforcement will be used similarly for both study groups. Following delivery of anesthesia, pulpotomy of maxillary first primary molars will be performed.
- Throughout the treatment procedure, if rescue anesthesia was needed, it will be delivered by needle infiltration in both study groups and recorded.
- Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
- Definitive examination and diagnosis for determination of eligibility, anesthetization, treatment, outcome measurement and data collection procedures will be all performed by the principal investigator.
- The principal investigator will be responsible for managing any intervention-related harms encountered by participants, both medically and financially, following-up the participant whenever necessary and providing post-operative prevention and oral hygiene instructions.
- All examination charts and outcome sheets will be labelled each with a specific code unique to every individual participant. Participant personal information will be kept confidential in a secured limited access area. All data will be electronically backed-up and securely stored by the principal investigator. Statistical analysis and interpretation of the collected results will be performed.
- All study results are planned to be disclosed and communicated to the public via a written thesis that will be orally presented and discussed in a defense that is to be held in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, in the presence of a selected jury. A manuscript of the trial work is planned to be prepared and submitted for publication.
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Apparently healthy (Classified as American Society of Anesthesiologists/ ASA I)
- Vital deeply carious maxillary first primary molars indicated for pulpotomy
- No previous dental experience
- Cooperative behavior (rating 3 or 4 on Frankl Category Rating Scale
Exclusion Criteria:
- Refuse to give assent to participate or have parents/caregivers refusing to sign the informed consent form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Jet anesthesia
Local infiltration anesthesia delivered using Madajet XL® (MADA Medical Products, Inc., Carlstadt, NJ, USA) needle-free jet injector
|
Other Names:
|
Active Comparator: Conventional infiltration anesthesia
Local infiltration anesthesia delivered using 25 gauged short needle attached, 1.8 ml carpule loaded standard metal dental syringe
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during pulpotomy score on Faces Pain Scale-Revised, aggregated by mean
Time Frame: Immediately following completion of pulpotomy procedure
|
|
Immediately following completion of pulpotomy procedure
|
Pain during pulpotomy score on Sound Eye Motor scale, aggregated by mean
Time Frame: Immediately following removal of dentin caries and initial access to pulp
|
|
Immediately following removal of dentin caries and initial access to pulp
|
Pain during pulpotomy score on Sound Eye Motor scale, aggregated by mean
Time Frame: Immediately following pulp extirpation
|
|
Immediately following pulp extirpation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain during injection score on Faces Pain Scale-Revised, aggregated by mean
Time Frame: Immediately following injection of local anesthesia
|
|
Immediately following injection of local anesthesia
|
Pain during injection score on Sound Eye Motor scale, aggregated by mean
Time Frame: Immediately following injection of local anesthesia
|
|
Immediately following injection of local anesthesia
|
Need for additional anesthesia, recorded as a binary (yes/no) outcome
Time Frame: Immediately following completion of treatment for participant
|
Rescue anesthesia recorded by principal investigator
|
Immediately following completion of treatment for participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lobna S. Mohamed, B.D.S., Cairo University
- Study Chair: Randa Y. Abd Al Gawad, Ph.D., Cairo University
- Study Director: Mariam M. Aly, Ph.D., Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2019
Primary Completion (Anticipated)
May 1, 2020
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
April 12, 2019
First Submitted That Met QC Criteria
April 12, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
- Children
- Local anesthesia
- Primary molars
- Pediatric patients
- Pulpotomy
- Vital pulp therapy
- Jet injection
- Jet anesthesia
- Pressure anesthesia
- Needle-free anesthesia
- Needle-less anesthesia
- Needle-free injection
- Needle-less local anesthesia
- Needle-less syringe
- Needle infiltration anesthesia
- Needle injection
- Local infiltration anesthesia
- Child patients
Other Study ID Numbers
- CEBD-CU-2019-04-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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