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

March 24, 2023 updated by: Amira Ahmed Mahmoud Mohamed, Cairo University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modeling Resin Insertion Technique
Resin Composite (Tetric® N-Ceram Nano-hybrid incremental composite) / Wetting Agent (Modeling Resin, Bisco)
Procedure: 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.
Placebo Comparator: Conventional Resin Composite Incremental Placement Technique
Conventional resin composite incremental placement technique (Tetric® N-Ceram Nano-hybrid incremental composite)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Marginal Discoloration at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Marginal Integrity at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Color Match at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (outside the acceptable range).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Surface Roughness at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Anatomic form (wear) at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Retention of Restoration at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (complete loss of restoration).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Secondary Caries at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to bravo (Caries contiguous with the restoration margin).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 months
Time Frame: T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months
Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Mostafa Abdelhamid, Professor-Cairo University, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Modeling Resin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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