NCT07703176 Clinical and Radiographic Assessment of First Permanent Molars With Cention-N

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This trial targets 100 participants in total. It began in 2026-03-09 with a primary completion date of 2027-03-09.

Brief 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 Criteria

Inclusion Criteria: Clinical: 1. Children aged 8-10 years. 2. Children classified as ASA physical status I or II. 3. Children demonstrate positive or definitely positive behavior (scores 3 or 4 on the Frankl Behavior Rating Scale). 4. Children who are available for regular recall visits throughout the study period. 5. Presence of bilateral carious lesions in permanent first molars, with a clear description of lesion depth whenever possible. 6. Asymptomatic vital permanent first molars showing no clinical or radiographic signs of pathology. Radiographic: 1. Normal lamina dura and periodontal ligament space. 2. No apical radiolucency. Exclusion Criteria: Clinical: 1. Children with behavioral difficulties or without signed parental consent. 2. Children are classified as ASA physical status class III or higher. 3. Teeth presenting clinical signs of pulpitis or necrosis (e.g., nocturnal pain, fistula, abscess, pulp exposure, or pathological mobility). Radiographic: 1. Evidence of abnormal radiolucency involving the pulp chamber or root apex. 2. Detection of furcal bone radiolucency or abnormal root resorption.

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