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Completed

NCT Number: NCT05593159

Bioactive Restorative Material in Non-Carious Cervical Lesions

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.

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Key information

Conditions

Cervical Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Restorative Dentistry, Faculty of Dental Medicine, Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dentin Conditioning

Other

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

Other

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.

1-step adhesive

Other

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

Other

The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)

Dentin roughness

Other

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

Other

Using size-010 round carbide bur (H1SEM.205.010 VPE 5, Komet Dental, Lemgo, Germany) on a low-speed handpiece.

Primary outcomes

  1. Change in retention rate

    Time frame: 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 outcomes

  1. Change in marginal adaptation

    Time frame: 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.

  2. Change in restoration fracture

    Time frame: 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.

  3. Change in marginal discoloration

    Time frame: 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.

  4. Change in anatomic form

    Time frame: 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

  5. Change in surface texture

    Time frame: 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.

  6. Change in secondary caries

    Time frame: 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.

  7. Change in post-operative sensitivity with stimulation

    Time frame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year

    Rated by Modified visual analog scale (VAS).

  8. Change in post-operative sensitivity without stimulation

    Time frame: 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).

  9. Change in patient satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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