Clinical and Radiographic Assessment of First Permanent Molars With Cention-N
ConditionDental Caries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-10
SponsorMinia University
About this trial
: 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
This trial does not accept healthy volunteersQualifiers
Children aged 8-10 years.
Children classified as ASA physical status I or II.
Children demonstrate positive or definitely positive behavior (scores 3 or 4 on the Frankl Behavior Rating Scale).
Children who are available for regular recall visits throughout the study period.
Disqualifiers
Children with behavioral difficulties or without signed parental consent.
Children are classified as ASA physical status class III or higher.
Teeth presenting clinical signs of pulpitis or necrosis (e.g., nocturnal pain, fistula, abscess, pulp exposure, or pathological mobility).
Evidence of abnormal radiolucency involving the pulp chamber or root apex.
Trial design
Design model
Crossover
Treatments tested in this trial
Cention-N
DeviceFollowing 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
DeviceFollowing 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cention NExperimental treatment 1 intervention
Group B: Resin CompositeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Color Match (CM)
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)
Time frame
"3,6,12 months"2
Marginal Adaptation (MA)
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)
Time frame
"3,6,12 months"3
Marginal Discoloration (MD)
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)
Time frame
"3,6,12 months"4
Anatomic Form (AF)
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)
Time frame
"3,6,12 months"Secondary outcomes
1
Oral Health Related Quality of Life
Child Perceptions Questionnaire (CPQ8-10), long form : The original English version of the Child Perceptions Questionnaire for children aged 8-10 years (CPQ8-10) consists of 25 items distributed across four domains: • Oral symptoms (5 items). • Functional limitations (5 items). • Emotional well-being (5 items) • Social well-being (10 items). The questionnaire begins with an introductory section and includes two general items recording the child's age and sex. The core section comprises 25 questions arranged in a standardized sequence, numbered consecutively from 1 to 25
Time frame
1 yearLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Faculty of Dentistry, Minya universityRecruiting Minya, Asyut Governorate
Egypt
EgyptSponsors and contacts
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Source ClinicalTrials.gov