Discoloration, ToothNCT04515069
Survival of Hybrid Laminate Veneers Using Two Different Tooth Preparation Techniques:Randomized Clinical Trial
A study testing traditional technique of tooth preparation and aesthetic preevaluative temporary technique for tooth preparation in people with Discoloration, Tooth and Malformed Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the survival of laminate veneers constructed using a recent polymer-infiltrated ceramic network material following the aesthetic pre-evaluative temporary (APT) technique of tooth preparation in comparison to traditional technique. Read more about this study
- Who is it for?
- Ages 19 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Discoloration, Tooth, Malformed Tooth, Diastema
- What is being tested?
- traditional technique of tooth preparation and aesthetic preevaluative temporary technique for tooth preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Apr 2017to 5 May 2019
- 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 19 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient-related criteria:
- Patients consulting the outpatient clinic of the department of Fixed Prosthodontics, Faculty of Dentistry, Cairo University.
- Able to tolerate necessary restorative procedures.
- Provide written consent.
- Accepts the one year follow-up period.
- Tooth related criteria:
Show all 11Show fewer
- Malaligned and malformed teeth in the aesthetics zone
- Multiple spacing
- Diastema
- Slightly and moderately discolored teeth
- Good oral hygiene
Who cannot join
- Patient-related criteria:
- Medically compromised patients, as they would not be able to attend multiple appointments or might require special management.
- Uncooperative patients, who would not abide by the instructions or attend the appointments.
- Tooth related criteria:
- Deciduous teeth; as the study was targeting only permanent teeth.
- Teeth with previous restorations, which might add another variable to the study (type of old restorative material, extent of recurrent caries). This could also affect the bond of laminate veneers to tooth structure.
- Patients with parafunctional habits, large restorations, or excessive tooth wear.
- Initially, scaling and polishing was performed. Patients were instructed on improving their oral hygiene and maintaining effective plaque control. However, if their gingival health did not improve, they were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival of a Recent Polymer- Infiltrated Ceramic Network Laminate Veneer Material Using Aesthetic Preevaluative Temporary (APT) Technique Versus Traditional Technique in the Aesthetic Zone:Randomized Clinical Trial
The aim of this study was to evaluate the survival of laminate veneers constructed using a recent polymer-infiltrated ceramic network material following the aesthetic pre-evaluative temporary (APT) technique of tooth preparation in comparison to traditional technique.
Read the detailed description
Six recruited patients (4 females, 2 males; ranging from: 20-30 years old and with mean age 24.6 years), who needed indirect laminate veneer restorations were included in this study. Patients were selected from the outpatient clinic of the Department of Fixed Prosthodontics,Faculty of Dentistry, Cairo University The participants received a total of 54 laminate veneers between April 2017 and February 2018. Written informed consent was acquired from all participating patients. Randomization was done using a computer generated 2 column list by the aid of Random.org in a 1:1 ratio. Allocation concealment was achieved using numbered cards in opaque sealed envelopes. Aluminium foil was placed inside the envelope to render the envelope impermeable to intense light. These envelopes were placed in a box and each participant was allowed to grasp one envelop the day of operation. Allocation concealment was performed by an investigator with no clinical involvement in the trial. This study is a single blinded study as the assessor was blinded to the assigned study groups. Blinding of the participants was not applicable as one of the techniques required extra visits. Blinding of the operator was not applicable as one clinician performed the tooth preparation in both techniques.A total of 54 laminate veneers were divided into two equal groups (n=27) according to the technique of tooth preparation: group T: traditional technique and group A: aesthetic pre-evaluative temporary technique. VITA ENAMIC material was used for CAD/CAM construction of laminate veneers. Cementation was performed using a light cured resin cement. The laminate veneers were evaluated at baseline, after 3, 6 and 12 months according to the modified United States Public Health Service (USPHS) criteriea. The data was collected, tabulated and statistically analyzed.
- Conditions
- Discoloration, Tooth, Malformed Tooth, Diastema
- Being tested
- traditional technique of tooth preparation, aesthetic preevaluative temporary technique for tooth preparation
- Keywords
- veneers, hybrid ceramics, CAD/CAM, tooth preparation techniques, USPHS criteria
- Medical subject headings
- Tooth Discoloration, Tooth Abnormalities, Diastema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional technique of tooth preparationProcedure or surgery
Also called Group T
Depth cutter wheels of predetermined depths (Komet, Germany) were used to perform the preparation directly on the tooth structure.
Depth cuts were performed on the labial surface using depth cutter wheels (Komet, Germany) with radius of 0.3 mm and 0.5 mm which is directly related to the thickness of the laminate veneers in the cervical and incisal one thirds respectively. Then islands of tooth structure between depth orientation grooves were removed.
Proximal reduction:
The interproximal reduction was completed just labial to the contact areas using a round end tapered diamond stone (Mani, Japan), and polishing was performed using polishing strips (Sof-Lex, 3M ESPE, Seefeld, Germany).
Incisal reduction:
Vertical depth grooves were created. Then, the round end tapered diamond stone (Mani, Japan)was used to create 1.5 mm incisal butt joint preparation.
Then, finishing and polishing of tooth preparation was performed.
aesthetic preevaluative temporary technique for tooth preparationProcedure or surgery
Also called Group A
The data obtained from digital smile design was used for construction of the diagnostic wax-up. The wax-up was then be transferred to the mouth using a silicone index, creating the aesthetic pre-evaluative temporary (APT). The APT was tested esthetically and functionally. Once approved by the operator and the patient, tooth preparation was performed through the APT. Depth cuts were performed similar to those performed in the traditional preparation with the difference of being prepared on the aesthetic pre-evaluative temporary instead of directly on the dental structure. Using tapered stone with round end (Mani, Japan), islands of tooth structure between depth orientation grooves were removed.
Proximal reduction, Incisal reduction Finishing and polishing of tooth preparation were carried out using the same technique as in the Group T with the difference of being performed through the APT, resulting in minimal tooth preparation
| Study group | Role | What they receive |
|---|---|---|
| Traditional technique for tooth preparation. | Active comparator | Tooth preparation performed directly on the tooth structure Receives: Procedure: traditional technique of tooth preparation |
| Aesthetic preevaluative temporary technique | Active comparator | Aesthetic pre-evaluative temporary (APT) was fabricated according the planned wax-up. Once the APT was approved both aesthetically and functionally, tooth preparation was performed through the APT. Receives: Procedure: aesthetic preevaluative temporary technique for tooth preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of laminate veneers using modified USPHS
Patients were called back after 1 week as the baseline to assess the veneer restorations. Assessment was carried out by an experienced observer blinded to the assigned study group for each patient. Laminate veneers were examined at baseline, after 3, 6 and 12 months according to the modified United States Public Health Service (USPHS) criteriae and the USPHS scores of Alfa, Bravo and Charlie were used for rating . Patients were also questioned about possible post-operative complaints. Digital photographs were made after placement of the veneers and during follow-up sessions.
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 posted17 Aug 2020
- Study start13 Apr 2017
- Primary completion20 Mar 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoloration, ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Attia, Cairo University
- Investigators
- Hanaa Zaghloul, PhD, Study director, Professor of Fixed Prosthodontics, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515069
- Sponsor's protocol ID
- 151021
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival of a Recent Polymer- Infiltrated Ceramic Network Laminate Veneer Material Using Aesthetic Preevaluative Temporary (APT) Technique Versus Traditional Technique in the Aesthetic Zone:Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04515069
- Acronym / sponsor ID
- 151021
- Conditions
- Discoloration, Tooth, Malformed Tooth, Diastema
- Keywords
- veneers, hybrid ceramics, CAD/CAM, tooth preparation techniques, USPHS criteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 17 Aug 2020 (actual)
- 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 was to evaluate the survival of laminate veneers constructed using a recent polymer-infiltrated ceramic network material following the aesthetic pre-evaluative temporary (APT) technique of tooth preparation in comparison to traditional technique.
Detailed description
Six recruited patients (4 females, 2 males; ranging from: 20-30 years old and with mean age 24.6 years), who needed indirect laminate veneer restorations were included in this study. Patients were selected from the outpatient clinic of the Department of Fixed Prosthodontics,Faculty of Dentistry, Cairo University The participants received a total of 54 laminate veneers between April 2017 and February 2018. Written informed consent was acquired from all participating patients. Randomization was done using a computer generated 2 column list by the aid of Random.org in a 1:1 ratio. Allocation concealment was achieved using numbered cards in opaque sealed envelopes. Aluminium foil was placed inside the envelope to render the envelope impermeable to intense light. These envelopes were placed in a box and each participant was allowed to grasp one envelop the day of operation. Allocation concealment was performed by an investigator with no clinical involvement in the trial. This study is a single blinded study as the assessor was blinded to the assigned study groups. Blinding of the participants was not applicable as one of the techniques required extra visits. Blinding of the operator was not applicable as one clinician performed the tooth preparation in both techniques.A total of 54 laminate veneers were divided into two equal groups (n=27) according to the technique of tooth preparation: group T: traditional technique and group A: aesthetic pre-evaluative temporary technique. VITA ENAMIC material was used for CAD/CAM construction of laminate veneers. Cementation was performed using a light cured resin cement. The laminate veneers were evaluated at baseline, after 3, 6 and 12 months according to the modified United States Public Health Service (USPHS) criteriea. The data was collected, tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional technique for tooth preparation. | Active comparator | Procedure: traditional technique of tooth preparationTooth preparation performed directly on the tooth structure |
| Aesthetic preevaluative temporary technique | Active comparator | Procedure: aesthetic preevaluative temporary technique for tooth preparationAesthetic pre-evaluative temporary (APT) was fabricated according the planned wax-up. Once the APT was approved both aesthetically and functionally, tooth preparation was performed through the APT. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patient-related criteria:
- Malaligned and malformed teeth in the aesthetics zone
- Multiple spacing
- Diastema
- Slightly and moderately discolored teeth
Key exclusion criteria (8 listed)
- Medically compromised patients, as they would not be able to attend multiple appointments or might require special management.
- Uncooperative patients, who would not abide by the instructions or attend the appointments.
- Deciduous teeth; as the study was targeting only permanent teeth.
- Teeth with previous restorations, which might add another variable to the study (type of old restorative material, extent of recurrent caries). This could also affect the bond of laminate veneers to tooth structure.
- Patients with parafunctional habits, large restorations, or excessive tooth wear.
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 |
|---|---|---|
| traditional technique of tooth preparationAlso: Group TDepth cutter wheels of predetermined depths (Komet, Germany) were used to perform the preparation directly on the tooth structure. Depth cuts were performed on the labial surface using depth cutter wheels (Komet, Germany) with radius of 0.3 mm and 0.5 mm which is directly related to the thickness of the laminate veneers in the cervical and incisal one thirds respectively. Then islands of tooth structure between depth orientation grooves were removed. Proximal reduction: The interproximal reduction was completed just labial to the contact areas using a round end tapered diamond stone (Mani, Japan), and polishing was performed using polishing strips (Sof-Lex, 3M ESPE, Seefeld, Germany). Incisal reduction: Vertical depth grooves were created. Then, the round end tapered diamond stone (Mani, Japan)was used to create 1.5 mm incisal butt joint preparation. Then, finishing and polishing of tooth preparation was performed. | Procedure or surgery | Traditional technique for tooth preparation. |
| aesthetic preevaluative temporary technique for tooth preparationAlso: Group AThe data obtained from digital smile design was used for construction of the diagnostic wax-up. The wax-up was then be transferred to the mouth using a silicone index, creating the aesthetic pre-evaluative temporary (APT). The APT was tested esthetically and functionally. Once approved by the operator and the patient, tooth preparation was performed through the APT. Depth cuts were performed similar to those performed in the traditional preparation with the difference of being prepared on the aesthetic pre-evaluative temporary instead of directly on the dental structure. Using tapered stone with round end (Mani, Japan), islands of tooth structure between depth orientation grooves were removed. Proximal reduction, Incisal reduction Finishing and polishing of tooth preparation were carried out using the same technique as in the Group T with the difference of being performed through the APT, resulting in minimal tooth preparation | Procedure or surgery | Aesthetic preevaluative temporary technique |
Primary outcome
Survival of laminate veneers using modified USPHS
Time frame: 1 year
Patients were called back after 1 week as the baseline to assess the veneer restorations. Assessment was carried out by an experienced observer blinded to the assigned study group for each patient. Laminate veneers were examined at baseline, after 3, 6 and 12 months according to the modified United States Public Health Service (USPHS) criteriae and the USPHS scores of Alfa, Bravo and Charlie were used for rating . Patients were also questioned about possible post-operative complaints. Digital photographs were made after placement of the veneers and during follow-up sessions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: Yes. Clinical Study Report
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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.
Hanaa Zaghloul, PhD study director
Professor of Fixed Prosthodontics, Misr International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional technique of tooth preparation and aesthetic preevaluative temporary technique for tooth preparation in people with Discoloration, Tooth and Malformed Tooth, run by Cairo University at 1 site in Egypt.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of laminate veneers using modified USPHS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2020.