Evaluating the Clinical Performance of a Bioactive Restorative Material in Non-Carious Cervical Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Lesion
- Sponsor
- Damascus University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in retention rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Evaluating the clinical performance of a bioactive restorative materiel (Cention N) placed in non-carious cervical lesions (NCCLs) with no preparation and 1-step adhesive system or, with preparing a gingival retentive groove and no adhesive system.
Detailed Description
Cention N is a relatively new restorative material that is known to be the first commercially available bioactive resin composite. The manufacturing company recommends using Cention N with 1-step adhesive system in non-retentive cavities, or with no adhesive system in retentive cavity preparations. This study was designed to evaluate the clinical performance of this material in non-carious cervical lesions by comparing it to RM-GIC (Fuji II LC). Information about oral and tooth brushing habits along with detailed information about the characteristics of each NCCL, gingival status, and preoperative sensitivity will be collected for each patient.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Good general health
- •with at least 20 teeth under occlusion
- •Should have three or more NCCLs which share the characteristics of being deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility
Exclusion Criteria
- •Poor oral hygiene
- •Severe periodontitis
- •Severe bruxism habits
- •Xerostomia
Outcomes
Primary Outcomes
Change in retention rate
Time Frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Rated by Modified United States Public Health Service criteria (USPHS) Alpha: Retained. Bravo: Partially retained. Charlie: Missing.
Secondary Outcomes
- Change in marginal adaptation(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in surface texture(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in secondary caries(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in restoration fracture(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in anatomic form(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in marginal discoloration(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in patient satisfaction(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in post-operative sensitivity with stimulation(Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year)
- Change in post-operative sensitivity without stimulation(Baseline: 1 day, follow-ups after 1 week, 1 month, 3 months, 6 months, 9 months, 1 year)