NCT04619264

Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Nourhan M.Aly · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in Alexandria, Egypt with mild to moderate dental pain due to caries. Participants were randomly assigned into Papacarie-Dup group (n=82) and ART group (n=80). The outcome variable was percent change in OHRQoL measured by OHIP-14.

Conditions

• Quality of Life
• Dental Caries

Interventions

Type	Name	Description
DRUG	Papacarie	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.
PROCEDURE	Atraumatic Restorative Treatment	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.

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-10-01
• Completion: 2019-10-20
• First posted: 2020-11-06
• Last updated: 2023-12-04

Locations

1 site across 1 country: Egypt