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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Jet anesthesia
Local infiltration anesthesia delivered using Madajet XL® (MADA Medical Products, Inc., Carlstadt, NJ, USA) needle-free jet injector
Device: Jet injector
  • The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection.
  • Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using Madajet XL injector as per the manufacturer's instructions.
  • A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration.
  • Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
  • All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated.
Other Names:
  • Madajet XL needle-free injector
  • Needle-less syringe
  • Needle-less injector
Active Comparator: Conventional infiltration anesthesia
Local infiltration anesthesia delivered using 25 gauged short needle attached, 1.8 ml carpule loaded standard metal dental syringe
Device: Needle attached dental syringe
  • The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection.
  • Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using standard needle-attached syringe in a classical local infiltration.
  • A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration.
  • Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
  • All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
  • Faces Pain Scale- Revised is a participant self-reported pain rating scale that consists of six line drawings of faces in different degrees of distress, scored along a 0-10 metric, measuring pain. The scale starts by a neutral face scored '0' representing no pain and ends with a frowning face scored '10' representing maximum pain. Scores increase in increments of 2.
  • The scale will be explained to the participant who will then be asked to choose the face that represents how much pain he/she feels. The pain score corresponding to the chosen face will be recorded.
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
  • Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1.
  • The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest.
  • Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
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
  • Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1.
  • The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest.
  • Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
Immediately following pulp extirpation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
  • Faces Pain Scale- Revised is a participant self-reported pain rating scale that consists of six line drawings of faces in different degrees of distress, scored along a 0-10 metric, measuring pain. The scale starts by a neutral face scored '0' representing no pain and ends with a frowning face scored '10' representing maximum pain. Scores increase in increments of 2.
  • The scale will be explained to the participant who will then be asked to choose the face that represents how much pain he/she feels. The pain score corresponding to the chosen face will be recorded.
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
  • Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1.
  • The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest.
  • Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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