Bioactive Restorative Material in Non-Carious Cervical Lesions

February 25, 2024 updated by: Damascus University

Evaluating the Clinical Performance of a 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic
        • Restorative Dentistry, Faculty of Dental Medicine, Damascus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dentin Conditioning & 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.
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.
Experimental: 1-step adhesive & 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)
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)
Experimental: Dentin roughness & Gingival retentive groove preparation & 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)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Director: Hussam Milly, PhD, Milly

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-OperativeDent-02-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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