NCT06485024

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

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

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 26, 2024

Last Update Submit

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

EXPERIMENTAL

the use of Modeling resin as the last layer applied to the NanoHybrid composite direct veneer

Device: Modeling Resin

comparator

ACTIVE COMPARATOR

the regular application of the NanoHybrid composite as a direct anterior veneer restoration

Device: Modeling Resin

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

comparatorintervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

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: 26850844BACKGROUND
  • 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.

    PMID: 21104100BACKGROUND
  • 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.

MeSH Terms

Conditions

Tooth WearDental Caries

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth Demineralization

Central Study Contacts

Asmaa A. Yassen, professor

CONTACT

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