Evaluation of Bioactive Giomer Material Versus Nanohybrid Resin Composite in Deep Marginal Elevation
NCT Number: NCT06497231
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Deep Caries|Dental Caries
Interventions: OTHER: Beautifil II LS|OTHER: Nanohybrid resin composite material
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-11-01

Summary:
This study will be conducted to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months.

Primary Outcome Measures: Post-operative sensitivity, Restorations will be assessed by testing of irritability of the pulpal nerve on cold, e.g., with dry ice or cold spray, in comparison to the reaction of a contralateral, sound, and unrestored tooth., Baseline (1 week after intervention), 6 months, 12 months and 24 months
Secondary Outcome Measures: Marginal adaptation, Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively., Baseline (1 week after intervention), 6 months, 12 months and 24 months|Occurrence of caries, Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively., Baseline (1 week after intervention), 6 months, 12 months and 24 months|Proximal Contact, Method of restorations assessment will be tactile using unwaxed dental floss to evaluate proximal contact tightness. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively., Baseline (1 week after intervention), 6 months, 12 months and 24 months|Plaque Index, Baseline (1 week after intervention), 6 months, 12 months and 24 months|Gingival Index, Baseline (1 week after intervention), 6 months, 12 months and 24 months|Interdental Pressure Index, Apical pressure of a horizontally placed periodontal probe is applied to evaluate periodontal tissue response. It is negative when gingival tissues are firm, bleeding-free, and slightly ischemic by the stimulation; otherwise it is positive., Baseline (1 week after intervention), 6 months, 12 months and 24 months|Papillary bleeding on probing Index, Baseline (1 week after intervention), 6 months, 12 months and 24 months|Probing Depth, Baseline (1 week after intervention), 6 months, 12 months and 24 months|Radiographic examination, Baseline (1 week after intervention), 6 months, 12 months and 24 months