Cervical Lesion
Conditions
Keywords
Non-carious cervical lesions (NCCLs), Composite restorations, Bioactive Restorative Material (Cention N), Adhesive
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.
Interventions
OTHERDentin Conditioning
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
OTHERRM-GIC
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.
OTHER1-step adhesive
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).
OTHERCention N
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
OTHERDentin roughness
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)
OTHERGingival retentive groove preparation
Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Clinical evaluation of restorations will be conducted by two trained and calibrated examiners. All examiners and patients are going to be blinded from group assignment. Allocation concealment will be done by using sequentially numbered, sealed/opaque envelopes.
Intervention model description
Split mouth design; each patient will receive three restorations, one for each arm of this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in retention rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in restoration fracture | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | Rated by modified USPHS. Alpha: None. Bravo: Small chip, but Clinically acceptable. Charlie: Failure due to bulk restorative fracture. |
| Change in marginal discoloration | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | 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. |
| Change in anatomic form | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | Rated by modified USPHS. Alpha: Appropriate contour. Bravo: Slightly over/under contoured. Charlie: Unacceptably over/under contoured |
| Change in surface texture | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | Rated by modified USPHS. Alpha: Enamel-like surface. Bravo: Surface rougher than enamel (clinically acceptable). Charlie: Surface unacceptably rough. |
| Change in marginal adaptation | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | 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. |
| Change in post-operative sensitivity with stimulation | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | Rated by Modified visual analog scale (VAS). |
| 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 | Rated by Modified visual analog scale (VAS). |
| Change in patient satisfaction | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | 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. |
| Change in secondary caries | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | Rated by modified USPHS. Alpha: No evidence of caries contiguous with the margin. Charlie: Evidence of presence of caries. |
Countries
Syria
Outcome results
None listed