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This randomized controlled trial aims to compare the clinical effectiveness of four ion-releasing restorative materials in the proximal cavities of primary molars that underwent selective caries removal. The main questions to answer are:
Participants will:
- visit the clinic 1st,3rd,6th,12th,18th,24th,30th and 36th months after the restoration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Hybrid Glass-ionomer Cement (Equia Forte HT) | Experimental | The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 10 seconds, and applied to the cavity in a single step. The restorative material was polymerized for 20 seconds using an LED light device (VALO, Ultradent, Utah, USA). Equia Forte Coat was applied and polymerized for 20 seconds. |
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| Device: Resin-Modified Glass-ionomer Cement (Fuji II LC) | Experimental | The material in capsule form was mixed in the mixer (Ultramat 2, SDI, Australia) for 10 seconds, and applied to the cavity in a single step. Polymerization was achieved using an LED light device (VALO, Ultradent, Utah, USA) for 20 seconds. |
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| Device: Bioactive Glass-Containing Alkasite (Cention N) | Experimental | The material was mixed using a plastic spatula on a mixing pad or glass with a powder-to-liquid ratio of 1:1 until it reached a homogeneous consistency, which took approximately 45 -60 seconds. Then the material was applied to the cavity and allowed to set for its self-curing time of 4 and a half minutes. |
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| Device: Zinc-Reinforced High-Viscosity Glass-ionomer Cement (ChemFil Rock) | Experimental | The material in capsule form was placed in the mixer (Ultramat 2, SDI, Australia) and mixed for 12 seconds, and applied to the cavity in a single step. In addition to the 90-second working time, an additional 4 and a half minutes were allowed for the material to cure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caries Removal | Procedure | The cavity preparation and restoration were performed by a single operator. Infected dentin tissue was selectively removed. The differentiation between infected and affected dentin was determined by the clinician through the visual-tactile method.Isolation was achieved with cotton rolls and suction. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation of the filling materials according to the modified USPHS criteria | Restorations were evaluated for retention, marginal discoloration, marginal adaptation, color stability, secondary caries, and postoperative sensitivity according to the modified USPHS with scores assigned as follows: the best being Alpha and the worst being Charlie. Each restoration received a score of Alpha, Bravo, or Charlie at each time interval. | Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months. |
| Measure | Description | Time Frame |
|---|---|---|
| Preservation of pulpal vitality | The modified USPHS criteria do not include the measure of pulpal vitality when evaluating the success of restorations. However, maintaining pulpal vitality is also a criterion for the success of a restoration and is assessed not by a graded score but by the presence or absence of symptoms and findings. In this study, pulpal vitality was clinically evaluated based on the presence or absence of percussion sensitivity, palpation sensitivity, gingival redness, fistula or abscess. If percussion sensitivity, palpation sensitivity, or the formation of a fistula or abscess were present, the restoration was classified as unsuccessful regarding pulpal vitality. In cases of gingival redness or unclear clinical symptoms, a periapical radiograph was taken. If presence or absence of radiolucency in the periapical or furcal area was detected in the radiograph, the restoration was classified as unsuccessful regarding pulpal vitality. |
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Inclusion Criteria:
For participants:
For teeth:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zulfikar Zahit Ciftci, Phd | Akdeniz University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akdeniz University | Antalya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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The materials were visually different from each other, which allowed the investigators to identify each material. As a result, masking could only be performed with the participants.
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| Filling | Procedure | Sectional matrix systems and interdental wedges were used to achieve an anatomical contour and contact. Then, the selected materials were placed in the cavity according to the manufacturers' recommendations. |
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| Evaluations were conducted at the 1st, 3rd, 6th, 12th, 18th, 24th, 30th and 36th months. |