Bioactive Restorative Material in Non-Carious Cervical Lesions

Not Applicable

Completed

• Conditions: Cervical Lesion
• Interventions: Other: 1-step adhesive; Other: Dentin Conditioning; Other: Cention N; Other: RM-GIC; Other: Dentin roughness; Other: Gingival retentive groove preparation

• Registration Number: NCT05593159
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2022-05-15
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-25
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-step adhesive & Cention N	Cention N	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)
Dentin Conditioning & RM-GIC	RM-GIC	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.
Dentin roughness & Gingival retentive groove preparation & Cention N	Cention N	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)
1-step adhesive & Cention N	1-step adhesive	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)
Dentin roughness & Gingival retentive groove preparation & Cention N	Dentin roughness	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)
Dentin Conditioning & RM-GIC	Dentin Conditioning	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.
Dentin roughness & Gingival retentive groove preparation & Cention N	Gingival retentive groove preparation	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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 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 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 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 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 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).

Trial Locations

Locations (1)

Restorative Dentistry, Faculty of Dental Medicine, Damascus University; 🇸🇾 Damascus, Syrian Arab Republic