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Clinical Trials/NCT02939417
NCT02939417UnknownNot Applicable

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

Marwa Salem0 sites16 target enrollmentStarted: November 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
16
Primary Endpoint
Marginal adaptation of laminate veneers

Study Overview

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.

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

  2. Enriching the professional skills of the dentist with a new material to improve the clinical performance of the restoration.

  3. Improving the confidence in the patient-dentist relationship.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Marginal adaptation of laminate veneers

Time Frame: 1 year

using USPHS criteria for clinical evaluation

Retention of laminate veneers

Time Frame: 1 year

using USPHS criteria for clinical evaluation

Fracture of laminate veneers

Time Frame: 1 year

using USPHS criteria for clinical evaluation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Marwa Salem
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Marwa Salem

Marwa Salem

Cairo University

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