CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 162 enrolled
Drug / intervention
Papacarie +1 moredrug
Likely dose
Not stated in 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/NCT04619264
NCT04619264Phase 2Completed

Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life: a Randomized Clinical Trial

Nourhan M.Aly·interventional·Posted Nov 6, 2020·Updated Dec 4, 2023

In Brief

A Phase 2 clinical trial evaluating Papacarie and Atraumatic Restorative Treatment for Quality of Life and Dental Caries. Completed, enrolled 162 participants across 1 site.

Detailed Summary

Aim of the study was to compare the effect of chemo-mechanical caries removal methods using Papacarie-Duo and alternative restorative treatment (ART) on the Oral Health Related Quality of Life (OHRQoL) of pregnant women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 6, 2020
Enrollment StartJan 10, 2019
Primary CompletionOct 1, 2019
Study CompletionOct 20, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.7 years ago

Interventions

Papacariedrug

First, tooth was cleaned with a wet cotton pellet. The gel was inserted using disposable syringe tip into the cavity and its color changed from clear to cloudy indicating the presence of infected tissues. After 40 seconds, the softened carious tissue was removed using excavator by gentle pressure. The remaining gel was removed with a cotton pellet. The procedure was repeated until there was no change in the gel color indicating that there was no more infected tissue.

Atraumatic Restorative Treatmentprocedure

The tooth was cleaned with a wet cotton pellet to remove debris and plaque and then isolated with cotton rolls to promote a dry environment. Caries was removed using a sharp excavator and the cavity was cleaned using a small wet cotton pellet and dried with a dry cotton pellet.