Bioactive Restorative Material in Non-Carious Cervical Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Clinical Performance of a Bioactive Restorative Material in Non-Carious Cervical Lesions

Conditions
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Cervical Lesion

Intervention / Treatment
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* Other: Dentin Conditioning
* Other: RM-GIC
* Other: 1-step adhesive
* Other: Cention N
* Other: Dentin roughness
* Other: Gingival retentive groove preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split mouth design; each patient will receive three restorations, one for each arm of this study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dentin Conditioning & RM-GIC<br>Dentin 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. RM-GIC: RM-GIC (Fuji II LC) will be applied in <2mm incremental layers afterward light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity. | Other: Dentin Conditioning<br>* 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<br>Other: RM-GIC<br>* 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.<br>|
| Experimental: 1-step adhesive & Cention N<br>1-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). Cention N: The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2) | Other: 1-step adhesive<br>* 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).<br>Other: Cention N<br>* The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)<br>|
| Experimental: Dentin roughness & Gingival retentive groove preparation & Cention N<br>Dentin 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) Gingival retentive groove preparation: Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece. Cention N: The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2) | Other: Cention N<br>* The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)<br>Other: Dentin roughness<br>* 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)<br>Other: Gingival retentive groove preparation<br>* Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retention rate | Rated by Modified United States Public Health Service criteria (USPHS) Alpha: Retained. Bravo: Partially retained. Charlie: Missing. | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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. | 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. | 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). | 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). | 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. | Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesive, Non-carious cervical lesions (NCCLs), Composite restorations, Bioactive Restorative Material (Cention N)