Clinical trial

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

NCT04619264

Name

minimally invasive & OHRQoL

Description

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.

Trial arms

Trial start

2019-01-10

Estimated PCD

2019-10-01

Trial end

2019-10-20

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Papacarie-Duo

Other names:

Papacarie-Duo

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.

Arms:

Atraumatic Restorative Treatment

Other names:

ART

Size

162

Primary endpoint

Change in Oral Health Related Quality of Life

up to 6 months

Retention of the final restoration

up to 6 months

Eligibility criteria

Inclusion Criteria: * Having at least one carious lesion involving dentine with lesion accessible to hand instruments (International Caries Detection and Assessment System score= 5 or 6). * Suffering from at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long. Exclusion Criteria: * Pregnant women with acute pulpitis, swelling or fistula. * Uncooperative patients and those who refused to participate.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 162, 'type': 'ACTUAL'}}

Updated at

2023-12-04

1 organization

1 product

2 indications

Organization

Product

Indication

Indication