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

The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women: a Randomized Clinical Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04573608
Enrollment
162
Registered
2020-10-05
Start date
2019-01-10
Completion date
2019-10-20
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pain, Patient Satisfaction

Keywords

Minimally Invasive Dentistry

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

Interventions

Papacarie was introduced into the cavity using the applicator and left for 40 seconds. A blunt excavator was used to remove the softened dentin. The remaining gel was removed using a cotton pellet. When there was no change in gel color, the cavity was considered caries free. The cavity was then filled with high viscosity glass ionomer cement (GIC) in an encapsulated form (Riva Self-Cure, SDI Limited, Bayswater, VIC, Australia). A mechanical mixer was used to mix the capsule for 10 seconds, the capsule was placed into the applicator to apply the GIC into the cavity. For occluso-proximal cavities, a matrix strip with a wooden wedge was used to provide the appropriate contour of the restoration. A gloved finger was used to apply pressure on the GIC for one minute and occlusion was checked and excess material was removed

The tooth was cleaned with a wet cotton pellet to remove debris and plaque. Caries was removed using sharp spoon excavators (Darby-Perry #220/221, #17 DE, Hu-Friedy, Chicago, USA), followed by cleaning the cavity using a small wet cotton pellet and finally dried with a dry cotton pellet. The cavity was considered caries-free when a leather-hard texture was reached and the excavator did not stick anymore. GIC was used to restore the cavity using the same technique described for the other group.

Sponsors

Alexandria University
CollaboratorOTHER
Nourhan M.Aly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain assessmentup to 6 monthsDifference 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 treatmentup to 6 monthsSatisfaction 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

MeasureTime frameDescription
Time to remove cariesProcedure (Immediately while treatment)Time to remove caries was recorded using a stop watch.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026