Bioactive Restorative Material in Non-Carious Cervical Lesions

NCT05593159 | Completed

• 1 other identifier: UDDS-OperativeDent-02-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Lesion

Keywords

Non-carious cervical lesions (NCCLs); Composite restorations; Bioactive Restorative Material (Cention N); Adhesive

Outcome Measures

Primary Outcomes (1)

• Change in retention rate

  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 Outcomes (9)

• Change in marginal adaptation

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

• Change in restoration fracture

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

• Change in marginal discoloration

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

• Change in anatomic form

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

• Change in surface texture

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

Study Arms (3)

Dentin Conditioning & RM-GIC

ACTIVE COMPARATOR

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; Other: RM-GIC

1-step adhesive & Cention N

EXPERIMENTAL

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; Other: Cention N

Dentin roughness & Gingival retentive groove preparation & Cention N

EXPERIMENTAL

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; Other: Dentin roughness; Other: Gingival retentive groove preparation

Interventions

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

Dentin Conditioning & RM-GIC

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.

Dentin Conditioning & RM-GIC

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).

1-step adhesive & Cention N

Cention N OTHER

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

1-step adhesive & Cention N; Dentin roughness & Gingival retentive groove preparation & Cention N

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)

Dentin roughness & Gingival retentive groove preparation & Cention N

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.

Dentin roughness & Gingival retentive groove preparation & Cention N

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Poor oral hygiene
• Severe periodontitis
• Severe bruxism habits
• Xerostomia

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Restorative Dentistry, Faculty of Dental Medicine, Damascus University

Damascus, Syria

Location

Related Publications (9)

• Bezerra IM, Brito ACM, de Sousa SA, Santiago BM, Cavalcanti YW, de Almeida LFD. Glass ionomer cements compared with composite resin in restoration of noncarious cervical lesions: A systematic review and meta-analysis. Heliyon. 2020 May 21;6(5):e03969. doi: 10.1016/j.heliyon.2020.e03969. eCollection 2020 May.

  PMID: 32462087 RESULT

• Francois P, Fouquet V, Attal JP, Dursun E. Commercially Available Fluoride-Releasing Restorative Materials: A Review and a Proposal for Classification. Materials (Basel). 2020 May 18;13(10):2313. doi: 10.3390/ma13102313.

  PMID: 32443424 RESULT

• Francois P, Remadi A, Le Goff S, Abdel-Gawad S, Attal JP, Dursun E. Flexural properties and dentin adhesion in recently developed self-adhesive bulk-fill materials. J Oral Sci. 2021 Mar 31;63(2):139-144. doi: 10.2334/josnusd.20-0448. Epub 2021 Feb 17.

  PMID: 33597335 RESULT

• Kim SY, Lee KW, Seong SR, Lee MA, Lee IB, Son HH, Kim HY, Oh MH, Cho BH. Two-year clinical effectiveness of adhesives and retention form on resin composite restorations of non-carious cervical lesions. Oper Dent. 2009 Sep-Oct;34(5):507-15. doi: 10.2341/08-006C.

  PMID: 19830963 RESULT

• Loguercio AD, Luque-Martinez IV, Fuentes S, Reis A, Munoz MA. Effect of dentin roughness on the adhesive performance in non-carious cervical lesions: A double-blind randomized clinical trial. J Dent. 2018 Feb;69:60-69. doi: 10.1016/j.jdent.2017.09.011. Epub 2017 Sep 27.

  PMID: 28962842 RESULT

• Panpisut P, Toneluck A. Monomer conversion, dimensional stability, biaxial flexural strength, and fluoride release of resin-based restorative material containing alkaline fillers. Dent Mater J. 2020 Aug 2;39(4):608-615. doi: 10.4012/dmj.2019-020. Epub 2020 Feb 7.

  PMID: 32037385 RESULT

• Swift EJ Jr, Perdigao J, Heymann HO, Wilder AD Jr, Bayne SC, May KN Jr, Sturdevant JR, Roberson TM. Eighteen-month clinical evaluation of a filled and unfilled dentin adhesive. J Dent. 2001 Jan;29(1):1-6. doi: 10.1016/s0300-5712(00)00050-6.

  PMID: 11137632 RESULT

• Vallittu PK, Boccaccini AR, Hupa L, Watts DC. Bioactive dental materials-Do they exist and what does bioactivity mean? Dent Mater. 2018 May;34(5):693-694. doi: 10.1016/j.dental.2018.03.001. Epub 2018 Mar 20. No abstract available.

  PMID: 29571660 RESULT

• Mustafa K, Alfakhry G, Milly H. Periodontal Evaluation for a New Alkasite Restorative Material in Noncarious Cervical Lesions: A Randomized-Controlled Clinical Trial. Clin Exp Dent Res. 2024 Dec;10(6):e70025. doi: 10.1002/cre2.70025.

  PMID: 39400529 DERIVED

Study Officials

• Hussam Milly, PhD

  Milly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical evaluation of restorations will be conducted by two trained and calibrated examiners. All examiners and patients are going to be blinded from group assignment. Allocation concealment will be done by using sequentially numbered, sealed/opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth design; each patient will receive three restorations, one for each arm of this study.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 25, 2022
• Study Start: May 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)