Clinical trial NCT05801458: Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique in Class I Lesions
Official title: Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique Versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class I Composite Restorations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Marginal Discoloration at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Secondary outcomes:
measure: Change from baseline in Marginal Integrity at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
measure: Change from baseline in Color Match at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
measure: Change from baseline in Surface Roughness at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
measure: Change from baseline in Anatomic form (wear) at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
measure: Change from baseline in Retention of Restoration at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
measure: Change from baseline in Secondary Caries at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
measure: Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 months
timeFrame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mostafa Abdelhamid, Professor-Cairo University
role: STUDY_DIRECTOR
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