NCT02939417

Brief Summary

The aim of this study is to evaluate the clinical performance of E-max veneers cemented with and without using grape seed extract before bonding.

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
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Status
unknown

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

October 17, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

October 17, 2016

Last Update Submit

October 18, 2016

Conditions

Retention & Fracture of Emax Laminate Veneers

Keywords

Laminate veneersGrape seed extractEmaxcollagen cross-linking agent

Outcome Measures

Primary Outcomes (3)

  • Retention of laminate veneers

    using USPHS criteria for clinical evaluation

    1 year

  • Fracture of laminate veneers

    using USPHS criteria for clinical evaluation

    1 year

  • Marginal adaptation of laminate veneers

    using USPHS criteria for clinical evaluation

    1 year

Study Arms (2)

using grape seed extract

EXPERIMENTAL

Grape seed extract as collagen cross-linking agent

Other: Grape seed extract

without uing grape seed extract

ACTIVE COMPARATOR
Other: Grape seed extract

Interventions

Grape seed extractOTHER

Grape seed extract - collagen cross-linking agent

using grape seed extractwithout uing grape seed extract

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients between 20-40 years old, able to read and sign the informed consent document.
  • Patients having teeth with exposed dentin surface limited to cervical third.
  • Patients, healthy physically and psychologically, able to tolerate conventional restorative procedures.
  • Patients don't have active periodontal or pulpal diseases and have teeth with good restorations.
  • Patients with normal occlusion.
  • Patients with teeth problems indicated for laminate veneer (e.g. discoloration, mild malposition, fracture not involving more than 50% enamel loss, ….)
  • Patients willing to return for follow-up examination and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with fractured teeth with more than 50% enamel loss.
  • Patients with poor oral hygiene and lack of motivation.
  • Pregnant women.
  • Patients with abnormal occlusion (eg. edge to edge, deep bite, …)
  • Patients with parafunctional habits (eg. Bruxism, biting on hard objects, …)
  • Patients with endodontically treated teeth.
  • Lack of opposite occluding dentition in the area intended for restoration.
  • Psychiatric problems or unrealistic expectations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Prasanth, V., Harshakumar, K., Lylajam, S., K, C. N. & Sreelal, T. Relation between fracture load and tooth preparation of ceramic veneers - an in vitro study. Heal. Sci. 2, 1-11 (2013).

    BACKGROUND

  • Jankar AS, Kale Y, Kangane S, Ambekar A, Sinha M, Chaware S. Comparative evaluation of fracture resistance of Ceramic Veneer with three different incisal design preparations - An In-vitro Study. J Int Oral Health. 2014 Feb;6(1):48-54. Epub 2014 Feb 26.

    PMID: 24653603BACKGROUND

  • Alghazzawi TF, Lemons J, Liu PR, Essig ME, Janowski GM. The failure load of CAD/CAM generated zirconia and glass-ceramic laminate veneers with different preparation designs. J Prosthet Dent. 2012 Dec;108(6):386-93. doi: 10.1016/S0022-3913(12)60198-X.

    PMID: 23217471BACKGROUND

  • Sadighpour L, Geramipanah F, Allahyari S, Fallahi Sichani B, Kharazi Fard MJ. In vitro evaluation of the fracture resistance and microleakage of porcelain laminate veneers bonded to teeth with composite fillings after cyclic loading. J Adv Prosthodont. 2014 Aug;6(4):278-84. doi: 10.4047/jap.2014.6.4.278. Epub 2014 Aug 14.

    PMID: 25177471BACKGROUND

  • da Costa DC, Coutinho M, de Sousa AS, Ennes JP. A meta-analysis of the most indicated preparation design for porcelain laminate veneers. J Adhes Dent. 2013 Jun;15(3):215-20. doi: 10.3290/j.jad.a29587.

    PMID: 23593640BACKGROUND

  • Ibarra G, Johnson GH, Geurtsen W, Vargas MA. Microleakage of porcelain veneer restorations bonded to enamel and dentin with a new self-adhesive resin-based dental cement. Dent Mater. 2007 Feb;23(2):218-25. doi: 10.1016/j.dental.2006.01.013. Epub 2006 Feb 24.

    PMID: 16499961BACKGROUND

  • Souza, P. & Lopes, L. G. Influence of the Resin Cement Color on the Shade of Porcelain Veneers After Accelerated Artificial Aging Influência da Cor do Cimento Resinoso na Tonalidade de Facetas de Porcelana Após Envelhecimento Artificial Acelerado. 21, (faculty of oral and dental medicine of cairo university, 2013).

    BACKGROUND

  • Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.

    PMID: 22821429BACKGROUND

  • Islam S, Hiraishi N, Nassar M, Yiu C, Otsuki M, Tagami J. Effect of natural cross-linkers incorporation in a self-etching primer on dentine bond strength. J Dent. 2012 Dec;40(12):1052-9. doi: 10.1016/j.jdent.2012.08.015. Epub 2012 Sep 11.

    PMID: 22982944BACKGROUND

  • Castellan CS, Pereira PN, Grande RH, Bedran-Russo AK. Mechanical characterization of proanthocyanidin-dentin matrix interaction. Dent Mater. 2010 Oct;26(10):968-73. doi: 10.1016/j.dental.2010.06.001. Epub 2010 Jul 21.

    PMID: 20650510BACKGROUND

MeSH Terms

Interventions

Grape Seed Extract

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical Preparations

Study Officials

  • Heba Hamza, Professor

    Faculty of Oral and Dental Medicine- Cairo University

    STUDY DIRECTOR

Central Study Contacts

Marwa Ayman Salem, Bachelor's degree

CONTACT

(+2)01002827601marwasalem107@gmail.com

Jylan El Guindy, Professor

CONTACT

(+2)01001671419dr_jul@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Marwa Salem

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 20, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 20, 2016

Record last verified: 2016-10