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

Phase 2

Completed

• Conditions: Dental Pain; Patient Satisfaction
• Interventions: Drug: Papacarie; Drug: Atraumatic Restorative Treatment

• Registration Number: NCT04573608
• Lead Sponsor: Nourhan M.Aly

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-20
• Study First Submitted: 2020-09-27
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-01
• Study First Posted: 2020-10-05
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain assessment	up to 6 months	Difference in pain was measured using Visual Analogue Scale (VAS). The scale is represented by a 100-mm-long horizontal line labeled "no pain" at one end and "worst pain" at the other end. Participants were asked to mark the place on the line representing their level of pain
Satisfaction with treatment	up to 6 months	Satisfaction with treatment was assessed using two questions: the first question was immediately following treatment: "Was the treatment carried out according to your expectations?" The second question was after 6 months" "Has the treatment solved the problem of your teeth?" Each question was answered on a 10-point scale, with lower values indicating a negative perspective and higher values indicating a positive experience.

Secondary Outcome Measures

Name	Time	Method
Time to remove caries	Procedure (Immediately while treatment)	Time to remove caries was recorded using a stop watch.

Trial Locations

Locations (1)

Family Health Centers; 🇪🇬 Alexandria, Egypt