Back to resultsImpact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life
Primary Purpose
Quality of Life, Dental Caries
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Papacarie
Atraumatic Restorative Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Quality of Life focused on measuring Minimally Invasive Caries Removal, Oral Health Related Quality of Life
Eligibility Criteria
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.
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
Change in Oral Health Related Quality of Life
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04619264
First Posted
November 1, 2020
Last Updated
November 1, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04619264
Brief Title
Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life
Official Title
Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Dental Caries
Keywords
Minimally Invasive Caries Removal, Oral Health Related Quality of Life
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
First, tooth was cleaned with a wet cotton pellet. The gel was inserted using disposable syringe tip into the cavity and its color changed from clear to cloudy indicating the presence of infected tissues. After 40 seconds, the softened carious tissue was removed using excavator by gentle pressure. The remaining gel was removed with a cotton pellet. The procedure was repeated until there was no change in the gel color indicating that there was no more infected tissue.
Intervention Type
Procedure
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 and then isolated with cotton rolls to promote a dry environment. Caries was removed using a sharp excavator and the cavity was cleaned using a small wet cotton pellet and dried with a dry cotton pellet.
Primary Outcome Measure Information:
Title
Change in Oral Health Related Quality of Life
Description
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.
Time Frame
up to 6 months
Title
Retention of the final restoration
Description
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.
Time Frame
up to 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant females in the first or second trimester
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
19505294
Citation
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Results Reference
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PubMed Identifier
24047844
Citation
Matsumoto SF, Motta LJ, Alfaya TA, Guedes CC, Fernandes KP, Bussadori SK. Assessment of chemomechanical removal of carious lesions using Papacarie Duo: randomized longitudinal clinical trial. Indian J Dent Res. 2013 Jul-Aug;24(4):488-92. doi: 10.4103/0970-9290.118393.
Results Reference
background
PubMed Identifier
29364329
Citation
Musskopf ML, Milanesi FC, Rocha JMD, Fiorini T, Moreira CHC, Susin C, Rosing CK, Weidlich P, Oppermann RV. Oral health related quality of life among pregnant women: a randomized controlled trial. Braz Oral Res. 2018;32:e002. doi: 10.1590/1807-3107bor-2018.vol32.0002. Epub 2018 Jan 22.
Results Reference
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PubMed Identifier
2197679
Citation
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
Results Reference
background
PubMed Identifier
29364343
Citation
Freitas MCCA, Fagundes TC, Modena KCDS, Cardia GS, Navarro MFL. Randomized clinical trial of encapsulated and hand-mixed glass-ionomer ART restorations: one-year follow-up. J Appl Oral Sci. 2018 Jan 18;26:e20170129. doi: 10.1590/1678-7757-2017-0129.
Results Reference
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PubMed Identifier
22466895
Citation
Al Habashneh R, Khader YS, Salameh S. Use of the Arabic version of Oral Health Impact Profile-14 to evaluate the impact of periodontal disease on oral health-related quality of life among Jordanian adults. J Oral Sci. 2012 Mar;54(1):113-20. doi: 10.2334/josnusd.54.113.
Results Reference
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PubMed Identifier
24838896
Citation
Motta LJ, Bussadori SK, Campanelli AP, Silva AL, Alfaya TA, Godoy CH, Navarro MF. Efficacy of Papacarie((R)) in reduction of residual bacteria in deciduous teeth: a randomized, controlled clinical trial. Clinics (Sao Paulo). 2014;69(5):319-22. doi: 10.6061/clinics/2014(05)04.
Results Reference
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PubMed Identifier
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Citation
Adham MM, El Kashlan MK, Abdelaziz WE, Rashad AS. Comparison of two minimally invasive restorative techniques in improving the oral health-related quality of life of pregnant women: a six months randomized controlled trial. BMC Oral Health. 2021 Apr 30;21(1):221. doi: 10.1186/s12903-021-01581-5.
Results Reference
derived
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Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life
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