Effect of Modeling Resin on Anterior Direct Composite Veneer
June 26, 2024 updated by: Sarah Azzazy ali, Cairo University
Clinical Performance of Direct NanoHybrid Resin Composite Veneer Restorations Applied With or Without Modeling Resin:a Randomized Controlled Trial
the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
ChatGPT This study aims to investigate the impact of modeling resin on the clinical performance of direct nanohybrid resin composite veneer restorations in anterior teeth. Resin composites are widely used in dental restorations due to their aesthetic qualities, but issues like discoloration and surface roughness can affect their longevity and patient satisfaction. Modeling resin, used to aid in composite placement and sculpting, has become common, but concerns exist regarding its effects on composite properties, particularly long-term color stability.
The research will employ a randomized controlled trial design with a two-arm parallel approach. Adult patients (18-45 years) with anterior tooth defects suitable for composite veneer restoration will be recruited. The intervention group will receive nanohybrid resin composite with modeling resin, while the comparator group will receive the composite without modeling resin. Outcomes will be assessed using modified USPHS criteria, including color stability, color match, anatomical form, marginal adaptation, marginal discoloration, retention rate, presence of secondary caries, and postoperative sensitivity, at baseline and at follow-up intervals of 1, 3, 6, and 12 months.
Statistical analysis will involve independent t-tests for intergroup comparisons and repeated measures ANOVA for intragroup comparisons, with a significance level set at 0.05. The study aims to determine if the use of modeling resin influences the clinical outcomes of resin composite veneer restorations. Ethics approval will be obtained, and confidentiality of participant data will be strictly maintained throughout the study period.
Overall, this research seeks to provide insights into optimizing the application of resin composites in dental practice to enhance patient outcomes and satisfaction
Study Type
Interventional
Enrollment (Estimated)
25
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 Contact
- Name: Sarah A. Azzazy, postgrad
- Phone Number: +02 10 18 300 996
- Email: sarah.azzazy@dentistry.cu.edu.eg
Study Contact Backup
- Name: Asmaa A. Yassen, professor
- Phone Number: +02 100 191 2610
- Email: Asmaa.Yassen@dentistry.cu.edu.eg
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
- 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.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention
the use of Modeling resin as the last layer applied to the NanoHybrid composite direct veneer
|
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
|
|
Active Comparator: comparator
the regular application of the NanoHybrid composite as a direct anterior veneer restoration
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comparison of Color stability with and without the intervention
Time Frame: baseline and after one year
|
by using Spectrophotometer to measure the color considering the intervention
|
baseline and after one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
comparing the effect of the intervention on color match
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
|
comparing the effect of the intervention on anatomical form
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
|
comparing the effect of the intervention on surface texture
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
|
comparing the effect of the intervention on marginal adaptation
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
|
comparing the effect of the intervention on marginal discoloration
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
|
comparing the effect of the intervention on retention rate
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
|
comparing the effect of the intervention on postoperative sensitivity
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
|
comparing the effect of the intervention on recurrent caries
Time Frame: baseline and after one year
|
using the modefied USPHS criteria
|
baseline and after one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Stefanski 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.
- 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.
- Rosentritt 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.
- Al-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.
- Bhadra 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.
- Crins 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.
- Demarco 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.
- Cortopassi 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.
- Malekipour 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.
- Gianordoli-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.
- Heintze 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.
- Maia 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.
- Paolone 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.
- Pizzolotto 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.
- Cetin 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.
- Sedrez-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.
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 (Estimated)
July 1, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
June 26, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
June 26, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MR in anterior
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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