Esthetic and Clinical Assessment of Injectable Resin Composite Technique

Clinical Performance Clinical Trial

Official title:

Esthetic and Clinical Assessment of Injectable Resin Composite Technique Compared to Conventional Layering Technique in Patients With Multiple Spacing in the Maxillary Anterior Teeth Area.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05945758
• Other study ID #: Injection Molding Technique
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Clinical Performance

Intervention

Procedure:
• Injectable resin composite technique.
A metal impression tray was filled with transparent vinyl polysiloxane (EXACLEAR, GC) and used to copy the stone model with the wax-up. Then, the replica will be separated from metal tray and a needle-shaped bur will be used to drill holes through the silicone key ending in the middle of the incisal edge. It will be checked whether the holes were large enough to enable the tip of the composite syringe to pass easily and completely. Neighbouring teeth (mesial and distal one) isolated using Teflon tape, as each tooth will individually be restored for establishment of satisfactory contact points. Following etching and rinsing, the tooth dried, and a dental cord (Ultrampak, Ultradent) will be packed into sulcus for mechanical prevention of subgingival composite flow. Then, the transparent silicone index will be placed in the correct intraoral position, and a syringe filled with flowable composite will be inserted through the hole on the incisal edge.
• Conventional layering technique
the palatal surface will be restored by enamel shade; adapted on the index in the spacing area then 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Esthetic anatomical form at 6,12,18& 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Secondary	Change from baseline in Color match and translucency at 6,12,18& 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Secondary	Change from baseline in Surface and marginal staining at 6,12,18& 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.
Secondary	Change from baseline in Surface lustrous at 6,12,18& 24 months.	FDI criteria. Possible scores range from 1 (Excellent) to 5 (Immediate replacement necessary).	T1: Baseline. T2: 6 months. T3: 12 months. T4: 18 months. T5: 24 months.