Clinical and Radiographic Assessment of First Permanent Molars With Cention-N

Condition(s) studied

Investigational drug(s) / intervention(s)

Cention-N: Following local anesthesia, rubber dam isolation, caries removal, and cavity preparation, enamel etching and adhesive application were performed. Cention N was hand-mixed according to the manufacturer's instructions (1 scoop powder:1 drop liquid), placed into the prepared cavity, adapted to the cavity walls, and condensed to ensure optimal marginal adaptation. Optional light curing for 20 seconds was performed, followed by finishing and polishing to obtain the final restoration.

Resin Composite: Following local anesthesia and rubber dam isolation, caries removal and cavity preparation were performed using a high-speed diamond bur under water cooling. Enamel margins were etched with 37% phosphoric acid for 30 seconds, rinsed, gently air-dried, and an adhesive system was applied and light-cured according to the manufacturer's instructions. The cavity was then restored with a bioactive injectable resin composite placed directly into the cavity and light-cured for 20 seconds. Finishing and polishing procedures were performed to achieve proper anatomical contour and smooth surface.

Study summary

: Assessment of Clinical, Radiographic, and Oral Health-Related Quality of Life Following Restoration of First Permanent Molars with Cention N: A 12-Month Split-Mouth Randomized Controlled Trial

Introduction

Dental caries is one of the most common chronic diseases affecting children. First permanent molars (FPMs) are particularly susceptible to caries because of their early eruption and complex occlusal anatomy. Restorative treatment aims to preserve tooth function and prevent disease progression. Composite resin is widely used because of its esthetics and mechanical properties; however, polymerization shrinkage may compromise marginal integrity. Cention N is a newer alkasite restorative material that releases fluoride, calcium, and hydroxide ions, promoting remineralization and enhancing caries resistance. Since treatment success should include both clinical outcomes and patient-centered outcomes, oral health-related quality of life (OHRQoL) will also be assessed.

Aim

To compare the clinical and radiographic performance of Cention N and bioactive injectable resin composite in restoring first permanent molars over 12 months. A secondary objective is to evaluate changes in children's oral health-related quality of life.

Materials and Methods

This will be a split-mouth randomized controlled clinical trial involving 100 children aged 8-10 years.

Inclusion criteria:

Healthy children (ASA I or II). Positive/definitely positive behavior (Frankl 3 or 4). Bilateral carious first permanent molars. Vital, asymptomatic teeth without radiographic pathology.

Exclusion criteria:

Lack of parental consent. ASA III or higher. Teeth with signs of irreversible pulp disease or radiographic pathology.

Ethical approval will be obtained from the Research Ethics Committee, Faculty of Dentistry, Minia University, and written informed consent will be obtained from parents.

Clinical Procedure

Following clinical and radiographic examination, local anesthesia and rubber dam isolation will be performed. Caries will be removed conservatively, followed by acid etching and adhesive application.

One molar will be restored with bioactive injectable resin composite according to the manufacturer's instructions.

The contralateral molar will be restored with Cention N, mixed and placed according to the manufacturer's instructions, with optional light curing.

All restorations will be finished and polished using standardized procedures.

Outcome Assessment

Primary outcome

Clinical and radiographic evaluation at 3, 6, and 12 months using the modified USPHS criteria, including:

Color match Marginal adaptation Marginal discoloration Anatomic form Secondary caries Restoration integrity

Secondary outcome Assessment of oral health-related quality of life using the Child Perceptions Questionnaire (CPQ8-10), which evaluates oral symptoms, functional limitations, emotional well-being, and social well-being.

Statistical Analysis

Collected data will be tabulated and analyzed using appropriate statistical methods to compare the performance of both restorative materials over the follow-up period.

Eligibility

Primary outcome measure(s)

• Color Match (CM) — "3,6,12 months"
  Degree of shade harmony between restoration and natural tooth measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)
• Marginal Adaptation (MA) — "3,6,12 months"
  Accuracy of the fit between restoration margins and tooth measured according the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)
• Marginal Discoloration (MD) — "3,6,12 months"
  Presence of staining along the restoration-tooth interface measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)
• Anatomic Form (AF) — "3,6,12 months"
  Ability of the restoration to reproduce natural tooth contour measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)
• Secondary Caries (SC) — "3,6,12 months"
  Development of caries adjacent to the restoration measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)
• Restoration Integrity (RI) — "3,6,12 months"
  Overall stability, wear resistance, and surface quality of the restoration measured according to the modified United States Public Health Services (USPHS) criteria with scores (α, β, γ, and σ)

Trial sites (1)

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