Effect of Modeling Resin on Anterior Direct Composite Veneer
Clinical Performance of Direct NanoHybrid Resin Composite Veneer Restorations Applied With or Without Modeling Resin:a Randomized Controlled Trial
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJuly 3, 2024
June 1, 2024
1 year
June 26, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
comparison of Color stability with and without the intervention
by using Spectrophotometer to measure the color considering the intervention
baseline and after one year
Secondary Outcomes (8)
comparing the effect of the intervention on color match
baseline and after one year
comparing the effect of the intervention on anatomical form
baseline and after one year
comparing the effect of the intervention on surface texture
baseline and after one year
comparing the effect of the intervention on marginal adaptation
baseline and after one year
comparing the effect of the intervention on marginal discoloration
baseline and after one year
- +3 more secondary outcomes
Study Arms (2)
intervention
EXPERIMENTALthe use of Modeling resin as the last layer applied to the NanoHybrid composite direct veneer
comparator
ACTIVE COMPARATORthe regular application of the NanoHybrid composite as a direct anterior veneer restoration
Interventions
it is the application of Modeling liquid to make easier manipulation and sculpting the composite veneer and reflect on its physical properties and clinical performance
Eligibility Criteria
You may qualify if:
- Adults (18-45Ys) with anterior tooth defects indicated for direct composite veneer restoration.
- Males or females.
- Community-dwelling
- Have all his/her anterior teeth with sufficient enamel structure
- With ≥ 1 anterior tooth defect
- Have sufficient cognitive ability to understand consent procedures
- Anterior tooth defect indicated for direct composite veneer
- Vital upper or lower anterior teeth with no signs or symptoms of irreversible pulpitis.
- Mobility grade: no clinical mobility
- Plaque index ≤ 2
You may not qualify if:
- Patients younger than 18 or older than 45 years old • Disabilities.
- Systemic diseases or severe medically compromised.
- Lack of compliance.
- Evidence of severe bruxism, clenching or temporomandibular joint disorders.
- Cognitive impairment
- Periapical pathosis or signs of pulpal pathology.
- Malocclusion
- Possible prosthodontic restoration within 1 year.
- Non-vital tooth.
- Endodontically treated tooth.
- Severe periodontal affection or tooth indicated for extraction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (16)
Munchow EA, Sedrez-Porto JA, Piva E, Pereira-Cenci T, Cenci MS. Use of dental adhesives as modeler liquid of resin composites. Dent Mater. 2016 Apr;32(4):570-7. doi: 10.1016/j.dental.2016.01.002. Epub 2016 Feb 3.
PMID: 26850844BACKGROUNDStefanski S, van Dijken JW. Clinical performance of a nanofilled resin composite with and without an intermediary layer of flowable composite: a 2-year evaluation. Clin Oral Investig. 2012 Feb;16(1):147-53. doi: 10.1007/s00784-010-0485-8. Epub 2010 Nov 23.
PMID: 21104100BACKGROUNDRosentritt M, Esch J, Behr M, Leibrock A, Handel G. In vivo color stability of resin composite veneers and acrylic resin teeth in removable partial dentures. Quintessence Int. 1998 Aug;29(8):517-22.
PMID: 9807133RESULTAl-Asmar AA, Ha Sabrah A, Abd-Raheam IM, Ismail NH, Oweis YG. Clinical evaluation of reasons for replacement of amalgam vs composite posterior restorations. Saudi Dent J. 2023 Mar;35(3):275-281. doi: 10.1016/j.sdentj.2023.02.003. Epub 2023 Mar 4.
PMID: 37091274RESULTBhadra D, Shah NC, Kishan KV, Dedania MS. An in vitro comparative evaluation of commonly consumed catechu and catechu with lime on surface roughness and color stability of the conventional nano-hybrid composite. J Conserv Dent. 2019 Jan-Feb;22(1):87-91. doi: 10.4103/JCD.JCD_181_18.
PMID: 30820089RESULTCrins LAMJ, Opdam NJM, Kreulen CM, Bronkhorst EM, Sterenborg BAMM, Huysmans MCDNJM, Loomans BAC. Randomized controlled trial on the performance of direct and indirect composite restorations in patients with severe tooth wear. Dent Mater. 2021 Nov;37(11):1645-1654. doi: 10.1016/j.dental.2021.08.018. Epub 2021 Sep 6.
PMID: 34497023RESULTDemarco FF, Collares K, Correa MB, Cenci MS, Moraes RR, Opdam NJ. Should my composite restorations last forever? Why are they failing? Braz Oral Res. 2017 Aug 28;31(suppl 1):e56. doi: 10.1590/1807-3107BOR-2017.vol31.0056.
PMID: 28902236RESULTCortopassi LS, Shimokawa CAK, Willers AE, Sobral MAP. Surface roughness and color stability of surface sealants and adhesive systems applied over a resin-based composite. J Esthet Restor Dent. 2020 Jan;32(1):64-72. doi: 10.1111/jerd.12548. Epub 2019 Nov 18.
PMID: 31737981RESULTMalekipour MR, Sharafi A, Kazemi S, Khazaei S, Shirani F. Comparison of color stability of a composite resin in different color media. Dent Res J (Isfahan). 2012 Jul;9(4):441-6.
PMID: 23162586RESULTGianordoli-Neto R, Padovani GC, Mondelli J, de Lima Navarro MF, Mendonca JS, Santiago SL. Two-year clinical evaluation of resin composite in posterior teeth: A randomized controlled study. J Conserv Dent. 2016 Jul-Aug;19(4):306-10. doi: 10.4103/0972-0707.186446.
PMID: 27563176RESULTHeintze SD, Rousson V, Hickel R. Clinical effectiveness of direct anterior restorations--a meta-analysis. Dent Mater. 2015 May;31(5):481-95. doi: 10.1016/j.dental.2015.01.015. Epub 2015 Mar 13.
PMID: 25773188RESULTMaia TS, Lima TD, Ramos VM, Faria-E-Silva AL, Menezes MS. Effect of modeling liquids on resin composite roughness and color parameters after staining and toothbrushing. Braz Oral Res. 2023 Mar 31;37:e024. doi: 10.1590/1807-3107bor-2023.vol37.0024. eCollection 2023.
PMID: 37018806RESULTPaolone G, Mazzitelli C, Josic U, Scotti N, Gherlone E, Cantatore G, Breschi L. Modeling Liquids and Resin-Based Dental Composite Materials-A Scoping Review. Materials (Basel). 2022 May 24;15(11):3759. doi: 10.3390/ma15113759.
PMID: 35683057RESULTPizzolotto L, Moraes RR. Resin Composites in Posterior Teeth: Clinical Performance and Direct Restorative Techniques. Dent J (Basel). 2022 Nov 27;10(12):222. doi: 10.3390/dj10120222.
PMID: 36547038RESULTCetin AR, Unlu N. One-year clinical evaluation of direct nanofilled and indirect composite restorations in posterior teeth. Dent Mater J. 2009 Sep;28(5):620-6. doi: 10.4012/dmj.28.620.
PMID: 19822994RESULTSedrez-Porto JA, Munchow EA, Brondani LP, Cenci MS, Pereira-Cenci T. Effects of modeling liquid/resin and polishing on the color change of resin composite. Braz Oral Res. 2016 Aug 18;30(1):S1806-83242016000100275. doi: 10.1590/1807-3107BOR-2016.vol30.0088.
PMID: 27556554RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's student
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 3, 2024
Study Start
July 1, 2024
Primary Completion
July 1, 2025
Study Completion
August 1, 2025
Last Updated
July 3, 2024
Record last verified: 2024-06