Esthetic and Clinical Assessment of Injectable Resin Composite Technique

Not Applicable

Not yet recruiting

• Conditions: Clinical Performance
• Interventions: Procedure: Conventional layering technique; Procedure: Injectable resin composite technique.

• Registration Number: NCT05945758
• Lead Sponsor: Cairo University

Brief Summary

injectable resin composite technique will show a better clinical and esthetic performance compared to conventional layering resin composite technique in patients with multiple spacing in the maxillary anterior teeth area or not.

Detailed Description

The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The injection molding technique has the advantage of replicating the excellent anatomy defined by a lab-made diagnostic wax-up whereby it would be used for the fabrication of direct restorations, so excellent anatomy results, verifies aesthetics, phonetics, and occlusion, avoids misunderstandings, as it is easy to implement and repair.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-12
• Last Update Submitted: 2023-07-12
• Study First Posted: 2023-07-14
• Last Update Posted: 2023-07-14
• Study Start: 2023-08
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Sound and vital upper anterior teeth.
• Spacing in the maxillary anterior teeth area ranging from .5mm to 2mm.
• Minor misalignment, correction of peg laterals.

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Exclusion Criteria

• Non-vital, fractured, or cracked teeth.
• Teeth with caries or in need of replacement of existing restorations.
• Rampant caries, atypical extrinsic staining of teeth.
• Heavy occlusion and occlusal contacts or history of bruxism.
• Severe periodontal affection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spacing in the maxillary anterior teeth area treated with conventional layering composite technique.	Conventional layering technique	shade mapping of enamel and dentin, then isolation the teeth with rubber dam. Palatal index will be done on waxing up and applied against the palatal surface to check the adaptation of the index. Then, the enamel shade adapted on the index in the spacing area. index will be placed back on the anterior teeth to build the palatal wall. A brush will be used to adapt the composite to the margin. After removing excess material, light curing will be carried out for 20 seconds. The Unica matrix (Polydentia) will be used to restore the proximal wall, and to achieve a good seal with the palatal wall. The matrix can be stabilized with a wedge if necessary. Building the proximal wall using the enamel shade, and the incisal halo by using a dentin shade, the frame to layer the core of the restoration will be ready.
Spacing in the maxillary anterior teeth area treated with injectable resin composite technique.	Injectable resin composite technique.	The injectable composite resin technique is an indirect/direct method that uses a transparent silicone index for accurate and predictable translation of diagnostic wax-up into composite restorations without the need for tooth preparation. The Spaces will be restored with injectable resin composite.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Esthetic anatomical form at 6,12,18& 24 months.	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Color match and translucency at 6,12,18& 24 months.	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
Change from baseline in Surface and marginal staining at 6,12,18& 24 months.	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).
Change from baseline in Surface lustrous at 6,12,18& 24 months.	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).