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The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women

N

Nourhan M.Aly

Status and phase

Completed
Phase 2

Conditions

Dental Pain
Patient Satisfaction

Treatments

Drug: Papacarie
Drug: Atraumatic Restorative Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04573608
Papacarie vs ART in pregnant

Details and patient eligibility

About

The aim of the present study was to compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain in 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 dental pain due to caries not extending to pulp who were randomly assigned into Papacarie-Duo group (n=82) and ART group (n=80) after stratification by number of treated surfaces

Enrollment

162 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pregnant females in the first or second trimester
  • Having at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long
  • Having at least one carious lesion involving dentine clinically classified as a shallow or medium cavity. This cavity should be accessible to hand instruments (International Caries Detection and Assessment System (ICDAS) score= 5 or 6.

Exclusion criteria

  • Pregnant women with acute pulpitis, swelling or fistula.
  • Uncooperative patients.
  • Patients with severe gingivitis (Gingival Index (GI) score=3).
  • Patients who are unable to read and/or write and those who refused to participate.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

162 participants in 2 patient groups

Papacarie-Duo
Experimental group
Treatment:
Drug: Papacarie
Atraumatic Restorative Treatment
Active Comparator group
Treatment:
Drug: Atraumatic Restorative Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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