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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

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ClinicalTrials.gov Identifier: NCT02939417
Recruitment Status : Unknown
Verified October 2016 by Marwa Salem, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Marwa Salem, Cairo University

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.

Condition or disease Intervention/treatment Phase
Retention & Fracture of Emax Laminate Veneers Other: Grape seed extract Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: using grape seed extract
Grape seed extract as collagen cross-linking agent
Other: Grape seed extract
Grape seed extract - collagen cross-linking agent

Active Comparator: without uing grape seed extract Other: Grape seed extract
Grape seed extract - collagen cross-linking agent




Primary Outcome Measures :
  1. Retention of laminate veneers [ Time Frame: 1 year ]
    using USPHS criteria for clinical evaluation

  2. Fracture of laminate veneers [ Time Frame: 1 year ]
    using USPHS criteria for clinical evaluation

  3. Marginal adaptation of laminate veneers [ Time Frame: 1 year ]
    using USPHS criteria for clinical evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939417


Contacts
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Contact: Marwa Ayman Salem, Bachelor's degree (+2)01002827601 marwasalem107@gmail.com
Contact: Jylan El Guindy, Professor (+2)01001671419 dr_jul@hotmail.com

Sponsors and Collaborators
Marwa Salem
Investigators
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Study Director: Heba Hamza, Professor Faculty of Oral and Dental Medicine- Cairo University

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).
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).

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Responsible Party: Marwa Salem, Cairo University
ClinicalTrials.gov Identifier: NCT02939417     History of Changes
Other Study ID Numbers: CEBC-CU-201610168
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marwa Salem, Cairo University:
Laminate veneers
Grape seed extract
Emax
collagen cross-linking agent

Additional relevant MeSH terms:
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Grape Seed Extract
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs