NCT03130855

Brief Summary

This split mouth randomized control trial is designed as to compare the effectiveness of the buccal infiltration technique with the gold standard inferior alveolar nerve block in anesthetizing mandibular second primary molars to undergoing pulpal treatment. patient will be videotaped during pulpal treatment of their teeth and an accessing pain will be through an objective pain scale (SEM scale), (sound-eye-motor scale). the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered during injecting the local anesthetic agent in both techniques.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

April 2, 2017

Last Update Submit

May 8, 2017

Conditions

Keywords

pediatric patientsarticaine local anesthesia

Outcome Measures

Primary Outcomes (1)

  • pain experienced by child during pulpal treatment

    sound-eye-motor

    one week

Secondary Outcomes (2)

  • time needed for numbness

    one week

  • pain experienced by the child due to needle prick

    one week

Study Arms (2)

inferior alveolar nerve block with 4% articaine

EXPERIMENTAL

inferior alveolar nerve block using 4% articaine anesthetic solution

Drug: inferior alveolar nerve block with 4% articaine

buccal infiltration with 4% articaine

ACTIVE COMPARATOR

buccal infiltration using 4% articaine anesthetic solution

Drug: buccal infiltration with 4% articaine

Interventions

an anesthetic technique using 4% articaine anesthetic solution

inferior alveolar nerve block with 4% articaine

anesthetic technique using 4% articaine anesthetic solution

buccal infiltration with 4% articaine

Eligibility Criteria

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

You may qualify if:

  • first dental visit.
  • cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 6 to 8 years suffering from one or more deep carious lesions in their primary molars seeking treatment.
  • Restorable molars with stainless steel crowns.

You may not qualify if:

  • medically compromised patients. uncooperative children (rating 1 or 2 on the Frankl behavior scale)needing special line of treatment through general anesthesia.
  • signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs or symptoms of any infection.
  • presence of any radiographic signs of abcess, bone loss, internal or external root resorption.
  • parents or guardians who refuse participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

omar sherif abo el abbas, bachelor

CONTACT

hany mohamed saber, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at pediatric dentistry and public health faculty of oral and dental medicine cairo university

Study Record Dates

First Submitted

April 2, 2017

First Posted

April 27, 2017

Study Start

May 15, 2017

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share