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

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

Interventions

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.

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.

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• Lobna S. Mohamed, B.D.S. · Cairo University

• Randa Y. Abd Al Gawad, Ph.D. · Cairo University

• Mariam M. Aly, Ph.D. · Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-31

Primary Completion

2020-05-31

Completion

2020-05-31

FDA Device

Yes