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

NCT05801458 | Unknown

• 1 other identifier: Modeling Resin
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Class I Composite Restorations

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Marginal Discoloration at 3,6,12 & 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 Outcomes (7)

• Change from baseline in Marginal Integrity at 3,6,12 & 18 months

  T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months

• Change from baseline in Color Match at 3,6,12 & 18 months

  T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months

• Change from baseline in Surface Roughness at 3,6,12 & 18 months

  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

  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

  T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months

Study Arms (2)

Modeling Resin Insertion Technique

EXPERIMENTAL

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

Procedure: Modeling Resin Insertion Technique

Conventional Resin Composite Incremental Placement Technique

PLACEBO COMPARATOR

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

Procedure: Conventional resin composite Incremental Placement Technique

Interventions

Modeling Resin Insertion Technique 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.

Modeling Resin Insertion Technique

Conventional resin composite Incremental Placement Technique 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.

Conventional Resin Composite Incremental Placement Technique

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants:
• Adult Patients (25-45).
• Good oral hygiene (plaque index score 0 or 1).
• Absence of damaging habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
• Teeth:
• Vital teeth with a normal appearance and morphology.
• Primary carious lesions in molar teeth.

You may not qualify if:

• Participants:
• Patients with bad oral hygiene.
• Patients with known allergic or adverse reaction to the tested materials.
• Any uncontrolled systemic disease, pregnant or lactating women and any patient incapable to be present at recall follow up visits.
• Teeth:
• Non-vital, fractured, or cracked teeth.
• Teeth with secondary caries or in need of replacement of existing restorations.
• Defective restorations adjacent to or opposite the tooth restored in the study.
• Rampant caries, atypical extrinsic staining of teeth.

Sponsors & Collaborators

• Cairo University: lead

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Study Officials

• Mostafa Abdelhamid, Professor-Cairo University

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Amira Mohamed, BDS, MSA University (2017)

CONTACT

01007615913; amira_mohamed@dentistry.cu.edu.eg

Dina El Kady, PhD -Cairo University

CONTACT

01004297317; dina.elkady@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Operator, main investigator and corresponding author

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 6, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-03