Caries prevalence of the first permanent molars in 6-8 years old children.
Fudong Zhu, Yao Chen, Yunxian Yu...
https://pubmed.ncbi.nlm.nih.gov/33439883/Actively Recruiting
Led by Minia University · Updated on 2026-07-15
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
This research evaluates the clinical and radiographic performance of two restorative materials, Cention N and bioactive injectable resin composite, in treating dental caries in first permanent molars of children aged 8 to 10 years. The study also examines how these treatments affect childrens oral health-related quality of life over a 12-month period. The trial uses a split-mouth randomized controlled design to compare outcomes within the same child, minimizing individual differences. Participants receive restorations in bilateral carious first permanent molars one tooth is treated with Cention N, a self-curing alkasite material releasing fluoride and other ions to support remineralization, while the other is treated with a resin composite, a widely used tooth-colored material. Both procedures involve local anesthesia, rubber dam isolation, caries removal, cavity preparation, enamel etching, adhesive application, and finishing and polishing. Treatments are performed according to manufacturers instructions, including optional light curing for Cention N. Children attend scheduled follow-up visits at 3, 6, and 12 months for clinical and radiographic assessments using modified USPHS criteria, evaluating color match, marginal adaptation, discoloration, anatomic form, secondary caries, and restoration integrity. Oral health-related quality of life is assessed at one year using the Child Perceptions Questionnaire CPQ8-10. The study includes monitoring of behavior, clinical signs, and radiographic status, with data analyzed to compare the two materials performance and impact on quality of life.
CONDITIONS
Clinical and Radiographic Assessment of First Permanent Molars With Cention-N
R
Rehab Gamal Madani, master
A
Ahmed Abdelhamid Elheeny, PhD
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Minia University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive local anesthesia and rubber dam isolation. Caries are removed, and cavities are prepared. One first permanent molar is restored with Cention N and the other with resin composite, following manufacturers' instructions. All restorations are finished and polished to proper anatomical contour and smoothness.
1 visit (in-person)
Duration - 12 months
Participants attend follow-up visits at 3, 6, and 12 months for clinical and radiographic evaluations of the restorations and to complete oral health-related quality of life questionnaires.
3 visits (in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor