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The objective of this study is to evaluate the micro-tensile bond strength of a newly self-adhesive resinous restorative material to dentin with and without application of universal bonding system (in-vitro) and to examine it's clinical performance by evaluation of it's color stability and marginal discoloration through a randomized clinical trial (in-vivo).
For color stability and marginal discoloration test, twenty class I cavities were prepared in the molar teeth of twenty different patients and then were randomly divided into two groups of ten patients each, where half of the molars was restored with Surefil one self-adhesive bulk-fill composite and the other half with Filtek One bulk-fill composite. A VITA Easyshade spectrophotometer was used to measure the baseline color of the restoration and at the margin after 24 hours and degree of color change and marginal discoloration after 3 months and 6 months of composite placement and then degree of color change (ΔE) was determined using the CIE L*a*b* system. All discolored restored molar teeth of both composite types were polished using a series of different thickness of Sof-Lex aluminum oxide discs (coarse, medium, fine), then the degree of color change of the restoration and at the margin (ΔE) was determined and was then compared to the baseline color measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surefil one bulk-fill composite | Experimental | Restorative material applied directly to the tooth without adhesive appliaction. |
|
| Filtek One bulk-fill composite | Active Comparator | Restorative material that is applied to the tooth after adhesive application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| self-adhesive resin restoration | Other | Light cured, hybrid resin composite material which contains polymerization modulator that lessens its degree of polymerization shrinkage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of color stability and marginal discoloration of resin restorations after aging in the patient mouth. | Clinical evaluation of degree of color change of resin restorations after aging in the patient mouth. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nourhan Samir Soliman, Assisstant Lecturer | Contact | 1066175951 | +20 | nourhan.samir@pua.edu.eh |
| Nermin Al-sayed Mahmoud, Associate professor | Contact | 1125529583 | +20 | nermin.alsayed@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Wael Essam Jamil, Professor | Faculty of Dental Medicine for Girls, AL-Azhar University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Minya University. | Recruiting | Minya | 61519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38655672 | Background | Ellithy MS, Abdelrahman MH, Afifi RR. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. J Esthet Restor Dent. 2024 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24. | |
| 35273277 | Background |
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Name Faculty Country
6 months
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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A total of 20 patients will be selected and divided randomly into two main groups according to the type of composite used, the first group will use Surefil one self-adhesive bulk-fill composite for restoring 10 posterior class I cavities and the second group will use 3M Filtek One high viscosity bulk-fill composite for restoring 10 posterior class I cavities.
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This study is a prospective randomized clinical trial with a follow up of 6 months. The clinical examiner and the participant will be kept unaware of the treatment being administrated.
|
| Rathke A, Pfefferkorn F, McGuire MK, Heard RH, Seemann R. One-year clinical results of restorations using a novel self-adhesive resin-based bulk-fill restorative. Sci Rep. 2022 Mar 10;12(1):3934. doi: 10.1038/s41598-022-07965-z. |
| 34129074 | Background | Cieplik F, Scholz KJ, Anthony JC, Tabenski I, Ettenberger S, Hiller KA, Buchalla W, Federlin M. One-year results of a novel self-adhesive bulk-fill restorative and a conventional bulk-fill composite in class II cavities-a randomized clinical split-mouth study. Clin Oral Investig. 2022 Jan;26(1):449-461. doi: 10.1007/s00784-021-04019-y. Epub 2021 Jun 15. |
| 38378771 | Background | Anwar RS, Hussein YF, Riad M. Optical behavior and marginal discoloration of a single shade resin composite with a chameleon effect: a randomized controlled clinical trial. BDJ Open. 2024 Feb 20;10(1):11. doi: 10.1038/s41405-024-00184-w. |
| 38481725 | Background | Fidan M. The effects of different repolishing procedures on the color change of bulk-fill resin composites. Eur Oral Res. 2024 Jan 5;58(1):14-21. doi: 10.26650/eor.20231234627. |
| 37875872 | Background | Uctasli MB, Garoushi S, Uctasli M, Vallittu PK, Lassila L. A comparative assessment of color stability among various commercial resin composites. BMC Oral Health. 2023 Oct 24;23(1):789. doi: 10.1186/s12903-023-03515-9. |