CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Maxillary infiltration anesthesia with 2%Lidocaine +1 moredrug
Likely dose
Maxillary infiltration anesthesia with 2%Lidocainefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02619981
NCT02619981Phase 4Completed

An Objective Assessment of Dental Fear, and the Influence of the Parental Presence on the Behavior of Anxious Children on Their First Restorative Dental Visit

Riyadh Colleges of Dentistry and Pharmacy·interventional·Posted Dec 2, 2015·Updated Dec 2, 2015

In Brief

A Phase 4 clinical trial evaluating Restorative procedure and Maxillary infiltration anesthesia with 2%Lidocaine for Dental Fear. Completed, enrolled 150 participants across 1 site.

Detailed Summary

150 children aged between five and seven years presenting for the first dental visit, whose parents consented to participate in the study were selected from patients reporting to the dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse rate for each patient was measured at different clinical situation starting from patient parent separation until end of appointment using a pulse oximeter, Data which collected was statistically analyzed using appropriate statistical analyses using SPSS ver.19 data processing software.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Fear
CountriesSaudi Arabia
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2015
Enrollment StartNov 1, 2012
Primary CompletionNov 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.6 years ago

Interventions

Restorative procedureprocedure

A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time

Maxillary infiltration anesthesia with 2%Lidocainedrug

1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle