Clinical trial NCT05593159: Bioactive Restorative Material in Non-Carious Cervical Lesions
Official title: Evaluating the Clinical Performance of a Bioactive Restorative Material in Non-Carious Cervical Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Lesion
Keywords: Non-carious cervical lesions (NCCLs)
Composite restorations
Bioactive Restorative Material (Cention N)
Adhesive
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth design; each patient will receive three restorations, one for each arm of this study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in retention rate
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Secondary outcomes:
measure: Change in marginal adaptation
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
measure: Change in restoration fracture
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
measure: Change in marginal discoloration
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
measure: Change in anatomic form
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
measure: Change in surface texture
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
measure: Change in secondary caries
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
measure: Change in post-operative sensitivity with stimulation
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
measure: Change in post-operative sensitivity without stimulation
timeFrame: Baseline: 1 day, follow-ups after 1 week, 1 month, 3 months, 6 months, 9 months, 1 year
measure: Change in patient satisfaction
timeFrame: Baseline: 1 week, follow-ups after 3 months, 6 months, 9 months, 1 year
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Restorative Dentistry, Faculty of Dental Medicine, Damascus University
Study officials:
affiliation: Milly
name: Hussam Milly, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.