NCT04317508

Brief Summary

Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 12, 2020

Last Update Submit

March 19, 2020

Conditions

Anesthesia, Dental

Keywords

benzocaineTopicaloral patchpaindental anesthesiachildren

Outcome Measures

Primary Outcomes (2)

  • Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% during injection

    The aim was to reduce pain and discomfort during injection of local anesthesia in pediatric dental patients. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale Sound, Eye, Motor scale: Grade 1: Comfort * Sound: No sound * Eye: No signs * Motor: Relaxed body and hand Grade 2: Mild discomfort * Sound: Non specific sound * Eye: Dilated without tears * Motor: Muscular contractions of hand Grade 3: Moderate discomfort * Sound: Verbal compliant, louder sound * Eye: Tears, sudden eye movement * Motor: Sudden body and hand movements Grade 4: Severe discomfort * Sound: Verbal compliant shouting, crying * Eye: Crying, tears all over face * Motor: Hand movement for defense, Turning the head to opposite side

    4 months

  • Comparing the tolerability of oral topical anesthetic Topicale GelPatch (Benzocaine 18%) and Benzocaine oral gel 20% after injection

    Pain or discomfort was evaluated after injection using faces pain scale-revised (FPS-R). 2- Face Pain Scale- Revised: Scoring the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" = "no pain" and "10" = "very much pain".

    4 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Topicale® topical anesthetic gel patch (Benzocaine 18%)

Drug: Topicale GelPatch (Benzocaine 18%)

control group

PLACEBO COMPARATOR

Opahl® topical anesthetic gel (Benzocaine 20%)

Drug: Benzocaine oral gel 20%

Interventions

Topicale GelPatch (Benzocaine 18%)DRUG

Intervention group

Intervention group
Benzocaine oral gel 20%DRUG

control group

control group

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ranging in age from 6 to 8 years.
  • Healthy children with no contraindications of use of local anesthetics.
  • Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I)
  • Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections.

You may not qualify if:

  • Uncooperative children or with intellectual or physical disabilities or medical conditions.
  • Children with acute pain or emergency visits.
  • Children with previous negative dental experience.
  • Children receiving premedications or analgesics 48 hours before testing.
  • children/parents not willing to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (2)

  • Bagesund M, Tabrizi P. Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa. Int J Paediatr Dent. 2008 Nov;18(6):452-60. doi: 10.1111/j.1365-263X.2007.00910.x. Epub 2008 Mar 12.

    PMID: 18341564RESULT

  • Stecker SS, Swift JQ, Hodges JS, Erickson PR. Should a mucoadhesive patch (DentiPatch) be used for gingival anesthesia in children? Anesth Prog. 2002 Winter;49(1):3-8.

    PMID: 12779107RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Huda M Ibrahim, BSc

    Alexandria University

    PRINCIPAL INVESTIGATOR

  • Amina Abdelrahman, PhD

    Alexandria University

    STUDY DIRECTOR

  • Aly Sharaf, PhD

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
* Administration of local anesthetic will be video recorded. * An independent investigator who is blinded to the type of topical applied will evaluate the outcome from the video recordings.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split mouth randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 23, 2020

Study Start

November 1, 2019

Primary Completion

February 13, 2020

Study Completion

February 19, 2020

Last Updated

March 23, 2020

Record last verified: 2020-03

Locations

EG(1)