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Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin

Primary Purpose

Class V Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conserved chalky white enamel margins of class V cavities
Total removal of demineralized enamel margins of class V cavities
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class V Dental Caries

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: class V carious lesions in premolars and molars. Vital upper or lower teeth with no signs of irreversible pulpitis. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth. Exclusion Criteria: Deep carious defects (close to pulp, less than 1 mm distance). Periapical pathology or signs of pulpal pathology. Endodontically treated teeth Tooth hypersensitivity. Possible prosthodontic restoration of teeth. Heavy occlusion or occlusal contacts or history of bruxism. Severe periodontal affection

Sites / Locations

  • Faculty of dentistry, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conservation of the demineralized chalky white enamel margin of class V cavities

Total removal of demineralized enamel margin of class V cavities

Arm Description

for cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration

for cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite

Outcomes

Primary Outcome Measures

marginal discoloration
ordinal criteria scoring system (ordinal)
marginal discoloration
ordinal criteria scoring system (ordinal)
marginal discoloration
ordinal criteria scoring system (ordinal)

Secondary Outcome Measures

color change
ordinal criteria scoring system (ordinal)
color change
ordinal criteria scoring system (ordinal)
color change
ordinal criteria scoring system (ordinal)

Full Information

First Posted
June 9, 2022
Last Updated
February 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05614076
Brief Title
Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin
Official Title
Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions
Detailed Description
With limited evidence-based information about the clinical performance of conserved white chalky enamel margins in class v .it is beneficial to compare the newly concept of preserved the white chalky deminerlized enamel margins using a randomized clinical trial to test the null hypothesis that this new concept has the same clinical performance as total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions .The comparator will be the concept of total removal of demineralized enamel margins in class v cavities restored with composite Patients are selected according to the eligibility criteria, Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For the comparator group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For interventional group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For control group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For experimental group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. both cavities groups restored with resin composite restorations. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class V Dental Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1
Masking
ParticipantOutcomes Assessor
Masking Description
Participant and Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservation of the demineralized chalky white enamel margin of class V cavities
Arm Type
Experimental
Arm Description
for cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration
Arm Title
Total removal of demineralized enamel margin of class V cavities
Arm Type
Active Comparator
Arm Description
for cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite
Intervention Type
Procedure
Intervention Name(s)
conserved chalky white enamel margins of class V cavities
Intervention Description
during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria
Intervention Type
Procedure
Intervention Name(s)
Total removal of demineralized enamel margins of class V cavities
Intervention Description
during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria
Primary Outcome Measure Information:
Title
marginal discoloration
Description
ordinal criteria scoring system (ordinal)
Time Frame
3 months
Title
marginal discoloration
Description
ordinal criteria scoring system (ordinal)
Time Frame
6 months
Title
marginal discoloration
Description
ordinal criteria scoring system (ordinal)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
color change
Description
ordinal criteria scoring system (ordinal)
Time Frame
3 month
Title
color change
Description
ordinal criteria scoring system (ordinal)
Time Frame
6 month
Title
color change
Description
ordinal criteria scoring system (ordinal)
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: class V carious lesions in premolars and molars. Vital upper or lower teeth with no signs of irreversible pulpitis. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth. Exclusion Criteria: Deep carious defects (close to pulp, less than 1 mm distance). Periapical pathology or signs of pulpal pathology. Endodontically treated teeth Tooth hypersensitivity. Possible prosthodontic restoration of teeth. Heavy occlusion or occlusal contacts or history of bruxism. Severe periodontal affection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Salim Dawood, master
Phone
00201011270500
Email
maryam.salim@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Refaat El-Bialy, PHD
Phone
00201202552666
Email
mohamed.refaat@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of dentistry, Cairo University
City
Cairo
ZIP/Postal Code
11511
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17467137
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
16421996
Citation
Bayne SC, Schmalz G. Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig. 2005 Dec;9(4):209-14. doi: 10.1007/s00784-005-0017-0. No abstract available.
Results Reference
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PubMed Identifier
16231497
Citation
Baratieri LN, Ritter AV. Critical appraisal. To bevel or not in anterior composites. J Esthet Restor Dent. 2005;17(4):264-9. doi: 10.1111/j.1708-8240.2005.tb00126.x.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
28621326
Citation
Kielbassa AM, Ulrich I, Schmidl R, Schuller C, Frank W, Werth VD. Resin infiltration of deproteinised natural occlusal subsurface lesions improves initial quality of fissure sealing. Int J Oral Sci. 2017 Jun;9(2):117-124. doi: 10.1038/ijos.2017.15. Epub 2017 Jun 16.
Results Reference
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PubMed Identifier
29152623
Citation
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Results Reference
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Citation
Lata S, Varghese NO, Varughese JM. Remineralization potential of fluoride and amorphous calcium phosphate-casein phospho peptide on enamel lesions: An in vitro comparative evaluation. J Conserv Dent. 2010 Jan;13(1):42-6. doi: 10.4103/0972-0707.62634.
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Citation
Koc Vural U, Kerimova L, Kiremitci A. Clinical comparison of a micro-hybride resin-based composite and resin modified glass ionomer in the treatment of cervical caries lesions: 36-month, split-mouth, randomized clinical trial. Odontology. 2021 Apr;109(2):376-384. doi: 10.1007/s10266-020-00550-8. Epub 2020 Sep 9.
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Brkanovic S, Ivanisevic A, Miletic I, Mezdic D, Jukic Krmek S. Effect of Nano-Filled Protective Coating and Different pH Enviroment on Wear Resistance of New Glass Hybrid Restorative Material. Materials (Basel). 2021 Feb 5;14(4):755. doi: 10.3390/ma14040755.
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Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin

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