Bioactive Restorative Material in Non-Carious Cervical Lesions
NCT ID: NCT05593159
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-05-15
2023-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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 afterword light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity.
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)
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)
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)
Cention N
The cavity will be restored using cention N followed by light curing for 10sec (1,000 mW/cm2)
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.
Interventions
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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 afterword light-cured for 10 sec (1,000 mW/cm2) per increment to fill the cavity.
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe periodontitis
* Severe bruxism habits
* Xerostomia
18 Years
ALL
Yes
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Hussam Milly, PhD
Role: STUDY_DIRECTOR
Milly
Locations
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Restorative Dentistry, Faculty of Dental Medicine, Damascus University
Damascus, , Syria
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UDDS-OperativeDent-02-2023
Identifier Type: -
Identifier Source: org_study_id
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