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Bioactive Restorative Material in Non-Carious Cervical Lesions

D

Damascus University

Status

Completed

Conditions

Cervical Lesion

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05593159
UDDS-OperativeDent-02-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 3 patient groups

Dentin Conditioning & RM-GIC
Active Comparator group
Description:
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.
Treatment:
Other: RM-GIC
Other: Dentin Conditioning
1-step adhesive & Cention N
Experimental group
Description:
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)
Treatment:
Other: 1-step adhesive
Other: Cention N
Dentin roughness & Gingival retentive groove preparation & Cention N
Experimental group
Description:
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)
Treatment:
Other: Dentin roughness
Other: Gingival retentive groove preparation
Other: Cention N

Trial contacts and locations

1

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Central trial contact

Milly; Hussam Milly, PhD

Data sourced from clinicaltrials.gov

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