Dental WearNCT06485024
Effect of Modeling Resin on Anterior Direct Composite Veneer
A study testing Modeling Resin in people with Dental Wear and Dental Decay, run by Cairo University.
Trial summary
the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Wear, Dental Decay
- What is being tested?
- Modeling Resin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 11Show fewer
- Malocclusion
- Possible prosthodontic restoration within 1 year.
- Non-vital tooth.
- Endodontically treated tooth.
- Severe periodontal affection or tooth indicated for extraction.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Conditions
- Dental Wear, Dental Decay
- Being tested
- Modeling Resin
- Medical subject headings
- Tooth Wear, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modeling ResinDevice
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
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | the use of Modeling resin as the last layer applied to the NanoHybrid composite direct veneer Receives: Device: Modeling Resin |
| comparator | Active comparator | the regular application of the NanoHybrid composite as a direct anterior veneer restoration Receives: Device: Modeling Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of Color stability with and without the intervention
by using Spectrophotometer to measure the color considering the intervention
Measured: baseline and after one year
Secondary outcomes (8)
comparing the effect of the intervention on color match
using the modefied USPHS criteria
Measured: baseline and after one year
comparing the effect of the intervention on anatomical form
using the modefied USPHS criteria
Measured: baseline and after one year
comparing the effect of the intervention on surface texture
using the modefied USPHS criteria
Measured: baseline and after one year
comparing the effect of the intervention on marginal adaptation
using the modefied USPHS criteria
Measured: baseline and after one year
comparing the effect of the intervention on marginal discoloration
using the modefied USPHS criteria
Measured: baseline and after one year
comparing the effect of the intervention on retention rate
using the modefied USPHS criteria
Measured: baseline and after one year
comparing the effect of the intervention on postoperative sensitivity
using the modefied USPHS criteria
Measured: baseline and after one year
comparing the effect of the intervention on recurrent caries
using the modefied USPHS criteria
Measured: baseline and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Dental WearStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Azzazy ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485024
- Sponsor's protocol ID
- MR in anterior
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26850844Stefanski 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.
PubMed 21104100Rosentritt 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.
PubMed 9807133Al-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.
PubMed 37091274Bhadra 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.
PubMed 30820089Crins 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.
PubMed 34497023Demarco 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.
PubMed 28902236Cortopassi 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.
PubMed 31737981Malekipour 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.
PubMed 23162586Gianordoli-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.
PubMed 27563176Heintze 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.
PubMed 25773188Maia 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.
PubMed 37018806Paolone 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.
PubMed 35683057Pizzolotto 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.
PubMed 36547038Cetin 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.
PubMed 19822994
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Direct NanoHybrid Resin Composite Veneer Restorations Applied With or Without Modeling Resin:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06485024
- Acronym / sponsor ID
- MR in anterior
- Conditions
- Dental Wear, Dental Decay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Modeling Resinthe use of Modeling resin as the last layer applied to the NanoHybrid composite direct veneer |
| comparator | Active comparator | Device: Modeling Resinthe regular application of the NanoHybrid composite as a direct anterior veneer restoration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- • Adults (18-45Ys) with anterior tooth defects indicated for direct composite veneer restoration.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modeling Resinit is the application of Modeling liquid to make easier manipulation and sculpting the composite veneer and reflect on its physical properties and clinical performance | Device | comparator, intervention |
Primary outcome
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
8 secondary outcomes
comparing the effect of the intervention on color match
Time frame: baseline and after one year
comparing the effect of the intervention on anatomical form
Time frame: baseline and after one year
comparing the effect of the intervention on surface texture
Time frame: baseline and after one year
comparing the effect of the intervention on marginal adaptation
Time frame: baseline and after one year
comparing the effect of the intervention on marginal discoloration
Time frame: baseline and after one year
comparing the effect of the intervention on retention rate
Time frame: baseline and after one year
comparing the effect of the intervention on postoperative sensitivity
Time frame: baseline and after one year
comparing the effect of the intervention on recurrent caries
Time frame: baseline and after one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 26850844Munchow 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.
- Background: PubMed 21104100Stefanski 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.
- Results publication: PubMed 9807133Rosentritt 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.
- Results publication: PubMed 37091274Al-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.
- Results publication: PubMed 30820089Bhadra 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.
- Results publication: PubMed 34497023Crins 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.
- Results publication: PubMed 28902236Demarco 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.
- Results publication: PubMed 31737981Cortopassi 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.
- Results publication: PubMed 23162586Malekipour 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.
- Results publication: PubMed 27563176Gianordoli-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.
- Results publication: PubMed 25773188Heintze 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.
- Results publication: PubMed 37018806Maia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Modeling Resin in people with Dental Wear and Dental Decay, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah A. Azzazy, postgrad (+02 10 18 300 996, sarah.azzazy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of Color stability with and without the intervention (time frame: baseline and after one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485024, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.