NCT05593159

Bioactive Restorative Material in Non-Carious Cervical Lesions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Lesion

Interventions

Type	Name	Description
OTHER	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
OTHER	RM-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.
OTHER	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).
OTHER	Cention N	The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
OTHER	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)
OTHER	Gingival retentive groove preparation	Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.

Timeline

• Start date: 2022-05-15
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2022-10-25
• Last updated: 2024-02-28

Locations

1 site across 1 country: Syria