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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05801458
Enrollment
50
Registered
2023-04-06
Start date
2023-05-01
Completion date
2024-11-01
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class I Composite Restorations

Brief summary

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

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.

Interventions

PROCEDUREModeling 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.

PROCEDUREConventional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in Marginal Discoloration at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).

Secondary

MeasureTime frameDescription
Change from baseline in Color Match at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (outside the acceptable range).
Change from baseline in Surface Roughness at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Anatomic form (wear) at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Marginal Integrity at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Secondary Caries at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to bravo (Caries contiguous with the restoration margin).
Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Retention of Restoration at 3,6,12 & 18 monthsT1: 3 months • T2: 6 months • T3: 12 months • T4: 18 monthsModified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (complete loss of restoration).

Contacts

Primary ContactAmira Mohamed, BDS, MSA University (2017)
amira_mohamed@dentistry.cu.edu.eg01007615913
Backup ContactDina El Kady, PhD -Cairo University
dina.elkady@dentistry.cu.edu.eg01004297317

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026