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This is a double blinded, randomized clinical study that evaluated the performance of a high filled injectable resin composite in polydiastema . The polydiastema disorders will be restored with high filled injectable resin composite (G'aenial Injectable Universal ) or anterior composite resin (G-aenial A'chord ). Restorations will be evaluated after 12 months according to FDI criteria and the data will be analyzed.
: The aim of this study was to comparatively evaluate the clinical performance of a high filled injectable resin composite with an anterior composite resin (G-aenial A'chord) in polidaiastemas.
Participants who are 18 years of age or older and healthy, and who have applied to the Restorative Dentistry Department of Hacettepe University Faculty of Dentistry to receive treatment for polidiastema disorders on their front teeth will be included in the study. After explaining the purpose and conditions of the study, they will be asked to sign an informed consent form. The gender, age, and tooth numbers of the participants to be treated will be recorded. 240 upper incisors of 60 patients will be treated, with attention paid to the balanced distribution of teeth in the right and left arches...Data were will be analyzed with Chi- Square, Fisher's Exact Test, Mann U tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectable | Experimental | G-aenial Injectable (high filled injectable resin composite) group This study planned to investigate the clinical performance of G-aenial Injectable Universal (high filled ınjectable resin composite) in the treatment of anterior polydiastema disorders. This arm of the study is the group whose effectiveness was investigated. The results will be evaluated by comparing with a traditional anterior resin composite in terms of functional, biological and aesthetic properties. |
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| Combine | Experimental | Restorations performed with a combined approach using a 1-mm palatal layer of nanohybrid composite resin (G-ænial A'Chord) followed by the injection of highly filled flowable composite resin (G-ænial Universal Injectable) guided by the PVS index. |
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| Conventional | Active Comparator | This group will serve as a "control". G-aenial Universal Injectable (high filled ınjectable resin composite) restorations will compare with the "G- Aenial A'chord" anterior resin composite restorations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanohybrid Composite (G-ænial A'Chord, GC Corp., Tokyo, Japan) | Device | Conventional nanohybrid resin composite (G-ænial A'Chord, GC Corp., Tokyo, Japan) was used for direct anterior veneer restorations. The material was applied using a free-hand layering technique following digital smile design and wax-up. A transparent silicone index (Exaclear, GC Corp.) was used for shape guidance when necessary. The enamel surfaces were etched with 37% phosphoric acid and bonded with a universal adhesive (G2 Bond, GC Corp.) before composite application. This intervention represents the standard clinical technique for direct composite veneers and serves as the active comparator group. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional properties score | The primary factor for determining the clinical performance of a restorative material is the Functional properties. Visual tactile examination tools will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12- months. The functional properties are scored as 1- clinically excellent, 2- clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure. [Time Frame: 1 year] | 1 year |
| Esthetic properties score | The secondary factor for determining the clinical performance of a restorative material is the Esthetic properties. Visual examination will be used for evaluating restorations according to FDI criteria by two experienced researchers at 1- week 6-, 12-months. The Esthetic properties are scored as 1- clinically excellent, 2-clinically good, 3-clinically sufficient/satisfactory, 4-clinically unsatisfactory 5-clinically poor (replacement necesessry). Clinically 1, 2 and 3 scores are clinical acceptable but 4 and 5 scores are designated as failure. | 1 year |
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Inclusion Criteria:
Polydiastema should be such that the mesial, distal and buccal surfaces of the tooth are included in the restoration.
Exclusion Criteria:
• 1.Participant must be under 18 years of age or over 35 years of age
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Faculty of Dentistry | Ankara | 06230 | Turkey (Türkiye) |
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| Highly Filled Injectable Composite (G-ænial Universal Injectable, GC Corp., Tokyo, Japan) | Device | Highly filled flowable injectable composite resin (G-ænial Universal Injectable, GC Corp., Tokyo, Japan) was used either as a sole restorative material or in combination with a nanohybrid composite for direct anterior veneers. For the injection process, a transparent PVS index (Exaclear, GC Corp.) was fabricated from a wax-up model and used to guide the placement of the material. In the combined technique, a 1-mm palatal layer of nanohybrid composite was placed first, followed by the injection of the flowable composite. The procedure aimed to improve adaptation, minimize voids, and optimize esthetic results compared to the conventional layering method. |
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