Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique in Class I Lesions

NCT ID: NCT05801458

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-11-01

Brief Summary

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Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial

Detailed Description

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Statement of the problem In a restorative procedure, an important objective is to obtain restorations with smooth surfaces. Surface roughness has a major influence on plaque accumulation, secondary caries, and gingival irritation. Further, it may directly influence wear behavior and the marginal integrity of composite restorations. A roughened surface of a resin composite restoration is also likely to be stained by exogenous sources, such as coffee, tea, or red wine, leading to the discoloration of the material.

One of the main drawbacks of sculpting composite restorations is that some materials are sticky, reducing the ease of handling and insertion of the material into the tooth cavity. Some materials readily adhere to the composite instruments; thus, limiting reestablishment of the shape and anatomical contour of the tooth. As a result, the application of lubricants on the composite instrument such as modeling liquids/resins between the layers of composite have been proposed.

Rationale Modeling resins can be directly applied between the layers using a brush or can be used as a lubricant on manual instruments. In both the aforementioned techniques, the ease of instrumentation during the placement of esthetic restorations is superior, compared to the traditional restorative techniques. Moreover, any pores or gaps on the surface of the composite placed by means of the layering technique can be easily resolved. Hence, the modeling resin facilitates the reduction of defects in the body of the restoration and aids in improving the mechanical properties.

Although these methods are widely used, a potential shortcoming is that these techniques may adversely affect the physical and surface properties of the resin composite. However, it is unknown whether different compositions of adhesives or modeling agents may affect the surface microhardness, surface roughness, and color stability of composites over time.

Conditions

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Class I Composite Restorations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Modeling Resin Insertion Technique

Resin Composite (TetricĀ® N-Ceram Nano-hybrid incremental composite) / Wetting Agent (Modeling Resin, Bisco)

Group Type EXPERIMENTAL

Modeling Resin Insertion Technique

Intervention Type PROCEDURE

One drop of modeling resin will be dispensed into a clean mixing well. Following the placement of the resin composite into the prepared site, a composite instrument (round-ended plugger with a diameter of 2 mm) will be dipped into the modeling resin. With modeling resin on the instrument, the resin composite is sculpted and manipulated to the desired shape. This will be repeated with each increment. Each increment will be polymerized for 20 sec with a LED light-curing unit.

Conventional Resin Composite Incremental Placement Technique

Conventional resin composite incremental placement technique (TetricĀ® N-Ceram Nano-hybrid incremental composite)

Group Type PLACEBO_COMPARATOR

Conventional resin composite Incremental Placement Technique

Intervention Type PROCEDURE

A three-step etch-and-rinse adhesive system will be used according to the manufacturer's instructions. 37.5% phosphoric acid (Kerr Co, Orange, CA, USA) will be applied to the enamel and dentin for a period of 30 s and 15 s, respectively. Subsequently the cavities will then be rinsed with an air/water spray for 15 s. A layer of primer will be applied to the dentin for 30 sec, afterward gentle air-drying for 5 sec. Then, the bond (AdheSE adhesive) will be applied on the enamel and dentin and light cured with a LED curing unit for about 30 sec. Tetric N-Ceram will then be applied using an incremental filling technique, each increment will not exceed 2mm in thickness. Each increment will be polymerized for 20 sec with a LED light-curing unit.

Interventions

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Modeling Resin Insertion Technique

One drop of modeling resin will be dispensed into a clean mixing well. Following the placement of the resin composite into the prepared site, a composite instrument (round-ended plugger with a diameter of 2 mm) will be dipped into the modeling resin. With modeling resin on the instrument, the resin composite is sculpted and manipulated to the desired shape. This will be repeated with each increment. Each increment will be polymerized for 20 sec with a LED light-curing unit.

Intervention Type PROCEDURE

Conventional resin composite Incremental Placement Technique

A three-step etch-and-rinse adhesive system will be used according to the manufacturer's instructions. 37.5% phosphoric acid (Kerr Co, Orange, CA, USA) will be applied to the enamel and dentin for a period of 30 s and 15 s, respectively. Subsequently the cavities will then be rinsed with an air/water spray for 15 s. A layer of primer will be applied to the dentin for 30 sec, afterward gentle air-drying for 5 sec. Then, the bond (AdheSE adhesive) will be applied on the enamel and dentin and light cured with a LED curing unit for about 30 sec. Tetric N-Ceram will then be applied using an incremental filling technique, each increment will not exceed 2mm in thickness. Each increment will be polymerized for 20 sec with a LED light-curing unit.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Participants:

1. Adult Patients (25-45).
2. Good oral hygiene (plaque index score 0 or 1).
3. Absence of damaging habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).

Teeth:

1. Vital teeth with a normal appearance and morphology.
2. Primary carious lesions in molar teeth.

Exclusion Criteria

Participants:

1. Patients with bad oral hygiene.
2. Patients with known allergic or adverse reaction to the tested materials.
3. Any uncontrolled systemic disease, pregnant or lactating women and any patient incapable to be present at recall follow up visits.

Teeth:

1. Non-vital, fractured, or cracked teeth.
2. Teeth with secondary caries or in need of replacement of existing restorations.
3. Defective restorations adjacent to or opposite the tooth restored in the study.
4. Rampant caries, atypical extrinsic staining of teeth.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amira Ahmed Mahmoud Mohamed

Operator, main investigator and corresponding author

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mostafa Abdelhamid, Professor-Cairo University

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Amira Mohamed, BDS, MSA University (2017)

Role: CONTACT

01007615913

Dina El Kady, PhD -Cairo University

Role: CONTACT

01004297317

References

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Other Identifiers

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Modeling Resin

Identifier Type: -

Identifier Source: org_study_id

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