Pain Control of Needle-free Versus Needle Injected Local Anesthesia for Pulpotomy of Upper Primary Molars in Children

NCT03917121 | Unknown FDA Device

• 1 other identifier: CEBD-CU-2019-04-05
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia, Local

Keywords

Jet anesthesia; Pressure anesthesia; Needle-free anesthesia; Needle-less anesthesia; Needle-free injection; Jet injection; Needle-less local anesthesia; Needle-less syringe; Needle infiltration anesthesia; Needle injection; Local infiltration anesthesia; Local anesthesia; Pulpotomy; Vital pulp therapy; Primary molars; Child patients; Pediatric patients; Children

Outcome Measures

Primary Outcomes (3)

• Pain during pulpotomy score on Faces Pain Scale-Revised, aggregated by mean

  * 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

  * 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

  * 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 Outcomes (3)

• Pain during injection score on Faces Pain Scale-Revised, aggregated by mean

  Immediately following injection of local anesthesia

• Pain during injection score on Sound Eye Motor scale, aggregated by mean

  Immediately following injection of local anesthesia

• Need for additional anesthesia, recorded as a binary (yes/no) outcome

  Immediately following completion of treatment for participant

Study Arms (2)

Jet anesthesia

EXPERIMENTAL

Local infiltration anesthesia delivered using Madajet XL® (MADA Medical Products, Inc., Carlstadt, NJ, USA) needle-free jet injector

Device: Jet injector

Conventional infiltration anesthesia

ACTIVE COMPARATOR

Local infiltration anesthesia delivered using 25 gauged short needle attached, 1.8 ml carpule loaded standard metal dental syringe

Device: Needle attached dental syringe

Interventions

Jet injector DEVICE

* 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.

Also known as: Madajet XL needle-free injector, Needle-less syringe, Needle-less injector

Jet anesthesia

Needle attached dental syringe DEVICE

* 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.

Conventional infiltration anesthesia

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Refuse to give assent to participate or have parents/caregivers refusing to sign the informed consent form

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Lobna S. Mohamed, B.D.S.

  Cairo University

  PRINCIPAL INVESTIGATOR

• Randa Y. Abd Al Gawad, Ph.D.

  Cairo University

  STUDY CHAIR

• Mariam M. Aly, Ph.D.

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Lobna S. Mohamed, B.D.S.

CONTACT

+20 10 6412 3124; lobna_mohamed@dentistry.cu.edu.eg

Mariam M. Aly, Ph.D.

CONTACT

+20 10 0524 1237; mariam.mohsen@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The duplicate outcome assessor (study director) and the assigned data analyst/ statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Parallel group trial with a 1:1 allocation ratio

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: August 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 24, 2019

Record last verified: 2019-07