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

Nourhan M.Aly

Status and phase: Completed; Phase 2

Conditions: Dental Caries; Quality of Life

Treatments: Procedure: Atraumatic Restorative Treatment; Drug: Papacarie

Study type: Interventional

Funder types: Other

Identifiers

NCT04619264

minimally invasive & OHRQoL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Papacarie-Duo

Experimental group

Treatment:

Drug: Papacarie

Atraumatic Restorative Treatment

Active Comparator group

Treatment:

Procedure: Atraumatic Restorative Treatment