CClinicalTrials.gg
Status unknownNCT02939417Updated Oct 20, 2016

One Year Clinical Evaluation of E.Max Laminate Veneers With and Without Using Grape Seed Extract as a Natural Collagen Cross-linking Agent Before Bonding

An interventional study of Grape seed extract in Retention & Fracture of Emax Laminate Veneers, sponsored by Marwa Salem. Status unknown. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-20.

Sponsored by Marwa Salem · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the detailed description

Justification for undertaking the trial:

Ceramic veneers have become a popular dental procedure since its introduction because they provide excellent esthetics.1 Achieving the good esthetic results especially with ceramic veneers is probably the most challenging task encountered by dental practitioners and ceramist today. Ceramic veneers are indicated for teeth with moderate discoloration, restoration of traumatized, fractured, worn dentition and abnormal tooth anatomy.2 Many factors affect the long term success of ceramic laminate veneers. The most repeated failure patterns associated with ceramic laminate veneer were fractures, microleakage, colour change and detachment of restoration.3 The main reasons for failure were large marginal defect and fractures.4 The clinical performance of ceramic veneer has shown that the estimated survival rate for the teeth prepared with butt joint design are higher than for the teeth prepared with palatal chamfer design.5 The bonding technique, which is a time-consuming and technique sensitive procedure, is a key to the long-term success of these types of restorations. The strength and the durability of the bond between the porcelain, the luting cement and the enamel/dentin interface play an important role in the outcome of ceramic veneers, particularly when dentin is involved. 6

Expected benefits for the patient

  1. Achieving a more predictable esthetic restoration while being conservative. 2. Increasing the long term prognosis of the restoration. Expected benefits for the clinician
  1. Enriching the professional skills of the dentist with a new material to improve the clinical performance of the restoration.
  2. Improving the confidence in the patient-dentist relationship.

Explanation for Choice of Comparators Resin cements are generally used for the bonding of all ceramic restorations since they provide adequate aesthetics, low solubility in oral environment, high bond strength to tooth structures, superior mechanical properties and support for ceramic.7 Since their retention relies solely on adhesion, durable adhesion of resin luting cements to both the enamel/dentin and the cementation surface of the ceramic is crucial. Luting cements used in conjunction with phosphoric acid etching followed by adhesive application on enamel show reliable adhesion.8 By studying the effect of incorporation of natural cross-linkers into the primer of a self-etching adhesive on resin-dentine bond strength, it had a positive influence on the immediate μTBS (micro tensile bond strength) and mechanical properties of the bonded interface.9

Statement of problem:

Ceramic veneers have become a popular dental procedure since its introduction because they provide excellent esthetics while being conservative. However, high failure rates of PLVs have been attributed to the exposure of dentin surface during preparation which greatly decrease the bonding strength at the dentin-cement interface. Natural and synthetic cross-linking agents have been introduced to restore dentin function, enhance bonding strength as well as positively affect the remineralization process in artificial roots. They have the ability to enhance the mechanical properties and stability of dentin matrix by the use of PA-rich collagen cross-linkers most likely due to the formation of a PA-collagen complex.10

Research hypothesis The null hypothesis of the study that there won't be a difference in the clinical performance \& adhesion of laminate veneers after application of grape seed extract before bonding.

02

Conditions studied

  • Retention & Fracture of Emax Laminate Veneers

Keywords

  • Laminate veneers
  • Grape seed extract
  • Emax
  • collagen cross-linking agent
03

In context

Lead sponsor

This is the only study on the registry with Marwa Salem as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients in the growth stage with partially erupted teeth.
  2. Patients with fractured teeth with more than 50% enamel loss.
  3. Patients with poor oral hygiene and lack of motivation.
  4. Pregnant women.
  5. Patients with abnormal occlusion (eg. edge to edge, deep bite, ...)
  6. Patients with parafunctional habits (eg. Bruxism, biting on hard objects, ...)
  7. Patients with endodontically treated teeth.
  8. Lack of opposite occluding dentition in the area intended for restoration.
  9. Psychiatric problems or unrealistic expectations.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    using grape seed extract

    Grape seed extract as collagen cross-linking agent

    Other: Grape seed extract

  • Active comparator
    without uing grape seed extract

    Other: Grape seed extract

Interventions

  • OtherGrape seed extract

    Grape seed extract - collagen cross-linking agent

06

What researchers measure

Primary outcomes

  1. Retention of laminate veneers

    using USPHS criteria for clinical evaluation

    Time frame: 1 year

  2. Fracture of laminate veneers

    using USPHS criteria for clinical evaluation

    Time frame: 1 year

  3. Marginal adaptation of laminate veneers

    using USPHS criteria for clinical evaluation

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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).
  • 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. PubMed 24653603 ↗
  • 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. PubMed 23217471 ↗
  • 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. PubMed 25177471 ↗
  • 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. PubMed 23593640 ↗
  • 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. PubMed 16499961 ↗
  • 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).
  • 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. PubMed 22821429 ↗
  • 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. PubMed 22982944 ↗
  • 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. PubMed 20650510 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02939417
Lead sponsor
Marwa Salem
Responsible party
Marwa Salem (Marwa Salem, Cairo University) — Sponsor-investigator
First posted
Oct 20, 2016
Start date
Nov 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Oct 20, 2016

Study contacts

Marwa Ayman Salem, Bachelor's degree
Contact
marwasalem107@gmail.com
(+2)01002827601
Jylan El Guindy, Professor
Contact
dr_jul@hotmail.com
(+2)01001671419
Heba Hamza, Professor
study director · Faculty of Oral and Dental Medicine- Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion