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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
After washing and drying -but not desiccating- Dentin Conditioner 20% (GC, Japan) will be applied using a cotton pellet for 20 seconds then rinsed thoroughly and gently dried
RM-GIC (Fuji II LC) will be applied in \<2mm incremental layers afterword light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity.
A universal adhesive system (Tetric® N-Bond Universal) will be applied on both enamel and dentin and gently scraped for 20 sec, then dispersed with oil-free gentle air stream, then light-cured for 10 sec (1,000 mW/cm2).
Restorative Dentistry, Faculty of Dental Medicine, Damascus University
Damascus, Syria
Change in retention rate
Rated by Modified United States Public Health Service criteria (USPHS) Alpha: Retained. Bravo: Partially retained. Charlie: Missing.
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in marginal adaptation
Rated by modified USPHS. Alpha: Restoration is continuous with existing anatomic form. Bravo: Detectable V-shaped defect in enamel only. Catches explorer going both ways. Charlie: Detectable V-shaped defect to dentin-enamel junction.
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in restoration fracture
Rated by modified USPHS. Alpha: None. Bravo: Small chip, but Clinically acceptable. Charlie: Failure due to bulk restorative fracture.
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in marginal discoloration
Rated by modified USPHS. Alpha: No discoloration along the margin. Bravo: Slight and superficial staining (removable, usually localized). Charlie: Deep staining cannot be polished away.
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in anatomic form
Rated by modified USPHS. Alpha: Appropriate contour. Bravo: Slightly over/under contoured. Charlie: Unacceptably over/under contoured
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in surface texture
Rated by modified USPHS. Alpha: Enamel-like surface. Bravo: Surface rougher than enamel (clinically acceptable). Charlie: Surface unacceptably rough.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
Using a round carbide bur size 14/16, (H1SEM.204.014 VPE5 or H1SEM.204.016 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. (No bevel preparation will be made)
Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in secondary caries
Rated by modified USPHS. Alpha: No evidence of caries contiguous with the margin. Charlie: Evidence of presence of caries.
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in post-operative sensitivity with stimulation
Rated by Modified visual analog scale (VAS).
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Change in post-operative sensitivity without stimulation
Rated by Modified visual analog scale (VAS).
Time frame: Baseline: 1 day, follow-ups after 1 week, 1 month, 3 months, 6 months, 9 months, 1 year
Change in patient satisfaction
Rated by modified USPHS. Alpha: Patient is totally satisfied. Bravo: Patient has esthetic complains, or complains related to the inability to chew comfortably. Charlie: Patient is completely unsatisfied.
Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year