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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Dental Pain, Patient Satisfaction

Intervention / Treatment
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* Drug: Papacarie
* Drug: Atraumatic Restorative Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Papacarie-Duo<br> | Drug: Papacarie<br>* 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<br>* Other names: Papacarie-Duo;|
| Active Comparator: Atraumatic Restorative Treatment<br> | Drug: Atraumatic Restorative Treatment<br>* 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.<br>* Other names: ART;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | 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 | up to 6 months | 
| Satisfaction with treatment | 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. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to remove caries | Time to remove caries was recorded using a stop watch. | Procedure (Immediately while treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally Invasive Dentistry