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

Primary Purpose

Dental Pain, Patient Satisfaction

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Papacarie
Atraumatic Restorative Treatment
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pain focused on measuring Minimally Invasive Dentistry

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Family Health Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Papacarie-Duo

Atraumatic Restorative Treatment

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Time to remove caries
Time to remove caries was recorded using a stop watch.

Full Information

First Posted
September 27, 2020
Last Updated
October 1, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04573608
Brief Title
The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women
Official Title
The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain, Patient Satisfaction
Keywords
Minimally Invasive Dentistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Papacarie-Duo
Arm Type
Experimental
Arm Title
Atraumatic Restorative Treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Papacarie
Other Intervention Name(s)
Papacarie-Duo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Atraumatic Restorative Treatment
Other Intervention Name(s)
ART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessment
Description
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
Time Frame
up to 6 months
Title
Satisfaction with treatment
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Time to remove caries
Description
Time to remove caries was recorded using a stop watch.
Time Frame
Procedure (Immediately while treatment)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant females only
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May M Adham, M.Sc
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mona K ElKashlan, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wafaa E Abdelaziz, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Family Health Centers
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
26962375
Citation
Maru VP, Shakuntala BS, Nagarathna C. Caries Removal by Chemomechanical (Carisolv) vs. Rotary Drill: A Systematic Review. Open Dent J. 2015 Dec 31;9:462-72. doi: 10.2174/1874210601509010462. eCollection 2015.
Results Reference
background
PubMed Identifier
27672245
Citation
Gugnani N, Pandit IK, Srivastava N, Gupta M, Sharma M. International Caries Detection and Assessment System (ICDAS): A New Concept. Int J Clin Pediatr Dent. 2011 May-Aug;4(2):93-100. doi: 10.5005/jp-journals-10005-1089. Epub 2010 Apr 15.
Results Reference
background
PubMed Identifier
14121956
Citation
LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
Results Reference
background
PubMed Identifier
33602209
Citation
Adham MM, El Kashlan MK, Abdelaziz WE, Rashad AS. The impact of minimally invasive restorative techniques on perception of dental pain among pregnant women: a randomized controlled clinical trial. BMC Oral Health. 2021 Feb 18;21(1):76. doi: 10.1186/s12903-021-01432-3.
Results Reference
derived

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

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