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The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
A recent review on clinical studies published on the performance of posterior composite restorations that were recalled at least up to 24-months reported that the overall failure rates for studies conducted between 2006-2016 was 13.13% and the two main reasons for failure in these two decades remained the same, i.e. secondary caries (25.68% - 29.47%) and composite fracture (28.84% - 39.07%). In in vitro studies, secondary caries has been attributed to interfacial gap or marginal defect both of which are consequences of polymerization contraction stresses. However, to date no clinical study has been able to directly establish a link between these stresses (and its consequences) to secondary caries. World Dental Federation (FDI) and United States Public Health Service (USPHS) clinical assessment criteria are the two main systems used to evaluate dental restorations in clinical trials. Both systems are designed to evaluate different properties of a restoration and properties pertaining to marginal integrity has been reported to be the most frequent properties investigated of a resin composite restoration. The grading descriptions for these properties are subjective and the discrimination between grading and between properties (especially between marginal stains and secondary caries) are problematic. Reasons to the lack of such a link is the discriminative deficiency of the clinical visual evaluation systems, the FDI and USPHS assessment criteria, and the ethical dilemma of restoration removal to assess for presence or absence of secondary caries. It has been long acknowledged that an objective clinical measuring tool and new clinical study designs for secondary caries is needed to further the understanding of secondary caries initiation and progression and how these relates to the marginal integrity of dental restorations. This brings forth the need of a sensitive yet clinically applicable assessment method for interfacial debonding and demineralization. Optical coherence tomography (OCT) is an optical, nondestructive and clinically- applicable technique that uses near infra red-light waves to provide cross-sectional images of structures. It is regarded as a standard-of-care equipment in ophthalmology and its clinical application has recently expanded to cardiology and dermatology. In dentistry, it has been used intra-orally in clinical trials to detect and quantify enamel demineralization and to detect mucosal and submucosal lesions. Optical coherence tomography and has been used to assess the performance of dental adhesives in a 12-month in vivo trial on non-carious cervical lesion. The authors reported that OCT outcome measures detected significant differences between groups while visual assessments did not. Hence supplementing the two visual assessment techniques with OCT outcome measures is expected to increase the sensitivity of short term interfacial debonding and demineralization changes. The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins |
|
| Group 2 | Experimental | Lesion-specific cavity design with wide bevel throughout the cavity margins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Composite with 90 degree cavosurface angle | Device | Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
Outcome will be reported as a single score at baseline. | Baseline |
| Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
Outcome will be reported as a single score at 6 months post-operative. | 6 months Follow-up |
| Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
Outcome will be reported as a single score at 18 months post-operative. | 18 months Follow-up |
| Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Backscattered Intensity at the Occlusal Cavosurface Angle. | Presence of elevated intensity at the cavosurface angle (margins) of the restoration, which indicates presence of minor marginal defect, is computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. | Baseline |
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Inclusion Criteria:
Tooth-level inclusion Criteria:
Exclusion Criteria:
- Signs of bruxism
Tooth-level exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hooi Pin Chew, BDS, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20628774 | Background | Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. | |
| 4515696 |
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Upon referral from the dental clinic or enquiries, potential participants were invited to attend a telemeeting where the participants were presented with the information of the trial using a MS Powerpoint slide deck. 46 participants were invited to the telemeeting and also attended an in-person screening session to determine whether they meet the inclusion criteria of the study. 36 met the inclusion criteria and were successfully enrolled into the study.
Participants were recruited based on referral from the dental clinics of the School of Dentistry University of Minnesota and enquiries from the public upon seeing flyers pasted at the Malcolm Moos Tower. The first and last participant were enrolled on 09/23/2021 and 7/15/22 respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | 90-degree Cavosurface Angle Cavity Margin | Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
| FG001 | Wide-bevel Cavity Margin | Lesion-specific cavity design with wide bevel throughout the cavity margins Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
Outcome will be reported as a single score at baseline. | Posted | Count of Participants | Participants | Baseline |
|
18 months
The interventions in both arms are topical one-surface dental resin composite restorations and there are no systemic interventions. Hence the number of participants at risk for All-Cause Mortality and Serious Adverse Events is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort upon biting on the tooth with dental restoration | Surgical and medical procedures | Non-systematic Assessment | Patient experienced discomfort upon biting on the tooth with the dental restoration about one week after restoration was done. The discomfort was relieved when pressure point was removed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hooi Pin Chew | University of Minnesota School of Dentistry | 6126256975 | chew0014@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2024 | May 2, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2021 | Apr 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Composite with wide bevel | Device | Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
|
| Baseline |
| Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 6 months post-operative. | 6 months Follow-up |
| Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 18 months post-operative. | 18 months Follow-up |
| Marginal Defect: World Dental Federation (FDI) Criteria - Baseline | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality. | Baseline |
| Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality. | 6 months Follow-up |
| Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality. | 18 months post-operative |
| Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at baseline. | Baseline |
| Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 6 months post-operative. | 6 months Follow-up |
| Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 18 months post-operative. | 18 months post-operative |
| Tooth-resin Interface Gap at the Occlusal Cavosurface Angle. | Presence of tooth-resin interface gap of more than 0.1 mm at the cavosurface angle (margins) of the restoration, which indicates presence of moderate marginal defect, will be computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. | Baseline |
| Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls | Presence of elevated backscattered intensity along the superficial 2mm depth walls of the restoration, which indicates presence of debonding, will be computed as percentage volume of the restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. | Baseline |
| Ryge G, Snyder M. Evaluating the clinical quality of restorations. J Am Dent Assoc. 1973 Aug;87(2):369-77. doi: 10.14219/jada.archive.1973.0421. No abstract available. |
| 23534012 | Background | Nazari A, Sadr A, Shimada Y, Tagami J, Sumi Y. 3D assessment of void and gap formation in flowable resin composites using optical coherence tomography. J Adhes Dent. 2013 Jun;15(3):237-43. doi: 10.3290/j.jad.a28623. |
| BG001 | Group 2 | Lesion-specific cavity design with wide bevel throughout the cavity margins Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Group 2 | Lesion-specific cavity design with wide bevel throughout the cavity margins Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. |
|
|
| Primary | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
Outcome will be reported as a single score at 6 months post-operative. | Posted | Count of Participants | Participants | 6 months Follow-up |
|
|
|
| Primary | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
Outcome will be reported as a single score at 18 months post-operative. | Posted | Count of Participants | Participants | 18 months Follow-up |
|
|
|
| Primary | Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at baseline. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 6 months post-operative. | Posted | Count of Participants | Participants | 6 months Follow-up |
|
|
|
| Primary | Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 18 months post-operative. | Posted | Count of Participants | Participants | 18 months Follow-up |
|
|
|
| Primary | Marginal Defect: World Dental Federation (FDI) Criteria - Baseline | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality. | Posted | Count of Participants | Participants | 6 months Follow-up |
|
|
|
| Primary | Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality. | Posted | Count of Participants | Participants | 18 months post-operative |
|
|
|
| Primary | Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at baseline. | Posted | Count of Participants | Participants | Baseline |
|
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| Primary | Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 6 months post-operative. | Posted | Count of Participants | Participants | 6 months Follow-up |
|
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| Primary | Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 18 months post-operative. | Posted | Count of Participants | Participants | 18 months post-operative |
|
|
|
| Secondary | Backscattered Intensity at the Occlusal Cavosurface Angle. | Presence of elevated intensity at the cavosurface angle (margins) of the restoration, which indicates presence of minor marginal defect, is computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. | Posted | Mean | Standard Error | Percentage area | Baseline |
|
|
|
| Secondary | Tooth-resin Interface Gap at the Occlusal Cavosurface Angle. | Presence of tooth-resin interface gap of more than 0.1 mm at the cavosurface angle (margins) of the restoration, which indicates presence of moderate marginal defect, will be computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. | Posted | Mean | Standard Error | Percentage | Baseline |
|
|
|
| Secondary | Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls | Presence of elevated backscattered intensity along the superficial 2mm depth walls of the restoration, which indicates presence of debonding, will be computed as percentage volume of the restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. | Posted | Mean | Standard Error | Percentage | Baseline |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Group 2 | Lesion-specific cavity design with wide bevel throughout the cavity margins Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. | 0 | 18 | 0 | 18 | 2 | 18 |
|
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| Score 3 |
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| Score 4 |
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| Score 5 |
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| Score 3 |
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| Score 4 |
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| Score 5 |
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| Score C |
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| Score C |
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| Score C |
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| Score C |
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| Score C |
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| Score C |
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