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

Phase 2

Completed

• Conditions: Quality of Life; Dental Caries
• Interventions: Procedure: Atraumatic Restorative Treatment; Drug: Papacarie

• Registration Number: NCT04619264
• Lead Sponsor: Nourhan M.Aly

Brief 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.

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-20
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-11-01
• Study First Posted: 2020-11-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atraumatic Restorative Treatment	Atraumatic Restorative Treatment	-
Papacarie-Duo	Papacarie	-

Primary Outcome Measures

Name	Time	Method
Change in Oral Health Related Quality of Life	up to 6 months	This was assessed by measuring changes between the Oral Health Impact Profile-14 (OHIP-14). The OHIP-14 includes 14 questions in seven dimensions with two questions for each dimension: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the OHIP-14 items were measured on a 5-pont Likert scale ranging from never = 0; hardly ever = 1; occasionally = 2; fairly often = 3; to very often = 4. The OHIP-14 score is the sum of the scores of the 14 statements and ranges from 0 to 56 and from 0 to 8 for each dimension with higher scores indicating higher frequency of negative impact.
Retention of the final restoration	up to 6 months	The scoring system was as follows: 0=present, without defect; 1=present, small defects on the margin measuring less than 0.5 mm in depth, with no need for repair; 2=present, small defects on the margin measuring 0.5 to 1.0 mm in depth, with need for repair; 3=present, gross defects on the margin measuring 1.0 mm or more in depth, with need for repair; 4=absent, restoration completely lost, need for treatment; 5=absent, other treatment had been performed for some reason; 6=tooth absent for some reason; 7=present, wear on surface less than 0.5 mm, with no need for replacement; 8=present, wear on surface greater than 0.5 mm, with need for replacement; 9=diagnosis impossible. Restorations having a score of 0, 1 or 7 were considered successful and those receiving a score of 2, 3, 4 or 8 were considered failures.

Trial Locations

Locations (1)

Family Health Centers; 🇪🇬 Alexandria, Egypt