Retention & Fracture of Emax Laminate VeneersNCT02939417
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
A study testing Grape seed extract in people with Retention & Fracture of Emax Laminate Veneers, run by Marwa Salem.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention & Fracture of Emax Laminate Veneers
- What is being tested?
- Grape seed extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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, …)
Show all 9Show fewer
- Patients with endodontically treated teeth.
- Lack of opposite occluding dentition in the area intended for restoration.
- Psychiatric problems or unrealistic expectations.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Achieving a more predictable esthetic restoration while being conservative. 2. Increasing the long term prognosis of the restoration. Expected benefits for the clinician
- Enriching the professional skills of the dentist with a new material to improve the clinical performance of the restoration.
- 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.
- Being tested
- Grape seed extract
- Keywords
- Laminate veneers, Grape seed extract, Emax, collagen cross-linking agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape seed extractOther
Grape seed extract - collagen cross-linking agent
| Study group | Role | What they receive |
|---|---|---|
| using grape seed extract | Experimental | Grape seed extract as collagen cross-linking agent Receives: Other: Grape seed extract |
| without uing grape seed extract | Active comparator | Not described Receives: Other: Grape seed extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of laminate veneers
using USPHS criteria for clinical evaluation
Measured: 1 year
Fracture of laminate veneers
using USPHS criteria for clinical evaluation
Measured: 1 year
Marginal adaptation of laminate veneers
using USPHS criteria for clinical evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Retention & Fracture of Emax Laminate VeneersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marwa Salem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Salem, Cairo University
- Investigators
- Heba Hamza, Professor, Study director, Faculty of Oral and Dental Medicine- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939417
- Sponsor's protocol ID
- CEBC-CU-201610168
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 24653603Alghazzawi 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 23217471Sadighpour 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 25177471da 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 23593640Ibarra 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 16499961Souza, 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 22821429Islam 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 22982944Castellan 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02939417
- Acronym / sponsor ID
- CEBC-CU-201610168
- Keywords
- Laminate veneers, Grape seed extract, Emax, collagen cross-linking agent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Marwa SalemUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Achieving a more predictable esthetic restoration while being conservative. 2. Increasing the long term prognosis of the restoration. Expected benefits for the clinician
- Enriching the professional skills of the dentist with a new material to improve the clinical performance of the restoration.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| using grape seed extract | Experimental | Other: Grape seed extractGrape seed extract as collagen cross-linking agent |
| without uing grape seed extract | Active comparator | Other: Grape seed extract |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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, …)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape seed extractGrape seed extract - collagen cross-linking agent | Other | using grape seed extract, without uing grape seed extract |
Primary outcome
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
Marginal adaptation of laminate veneers
Time frame: 1 year
using USPHS criteria for clinical evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- BackgroundPrasanth, 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: PubMed 24653603Jankar 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.
- Background: PubMed 23217471Alghazzawi 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.
- Background: PubMed 25177471Sadighpour 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.
- Background: PubMed 23593640da 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.
- Background: PubMed 16499961Ibarra 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.
- BackgroundSouza, 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: PubMed 22821429Gresnigt 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.
- Background: PubMed 22982944Islam 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.
- Background: PubMed 20650510Castellan 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba Hamza, Professor study director
Faculty of Oral and Dental Medicine- Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Grape seed extract in people with Retention & Fracture of Emax Laminate Veneers, run by Marwa Salem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Ayman Salem, Bachelor's degree ((+2)01002827601, marwasalem107@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of laminate veneers (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939417, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.