Teeth SensitivityNCT03214549
Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers
A study testing gull wing preparation of laminates veneers and conventional preparation of laminates veneers in people with Teeth Sensitivity, run by Cairo University.
Trial summary
The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain laminates veneers prepared with modified gull wing preparation and conventional preparation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Teeth Sensitivity
- What is being tested?
- gull wing preparation of laminates veneers and conventional preparation of laminates veneers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2018to 1 Oct 2018
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- From 18-40 years old, be able to read and sign the informed consent document.
- Be physically and psychologically able to tolerate conventional restorative Procedures.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Patients with teeth problems indicated for laminate veneer (e.g:discoloration, fracture not involve more than 50% enamel loss, mild malposition.
- Be willing to return for follow-up examinations and evaluation.
Who cannot join
- Patients in the growth stage with partially erupted teeth.
- Patient with fractured teeth of more than 50% enamel loss.
- Patients with poor oral hygiene and motivation.
- Pregnant women.
- Patient with post and core endodontically treated teeth.
- Psychiatric problems or unrealistic expectations.
- Lack of opposite occluding dentition in the area intended for restoration
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Marginal Adaptation of E.Max Laminate Veneers Prepared With Modified Gull Wing Preparation and Conventional Preparation
The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain laminates veneers prepared with modified gull wing preparation and conventional preparation.
Read the detailed description
Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radio-graphic examination and primary impression for diagnostic cast construction.
Visit 2: Teeth preparation, secondary impression,temporary restoration and teeth sensitivity evaluation using United States Public Health Service criteria.
Visit 3: Placement and permanent cementation of the final restoration
Visit 4: marginal adaptation measurement by electron microscope using impression replica.
- Conditions
- Teeth Sensitivity
- Being tested
- gull wing preparation of laminates veneers, conventional preparation of laminates veneers
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gull wing preparation of laminates veneersProcedure or surgery
Also called dog leg preparation of laminates veneers
preparation involving mesial and distal extension further lingualy.
conventional preparation of laminates veneersProcedure or surgery
preparation not involving mesial and distal extension further lingualy.
| Study group | Role | What they receive |
|---|---|---|
| gull wing preparation veneers | Active comparator | intervention: gull wing preparation in laminates veneers proximal margin of the preparation is placed toward the lingual .The area of the proximal margin between the contact area and the gingival papilla is placed even further to the lingual. This preparation design helps to hide the margin when the restorations are viewed from an angle. Receives: Procedure: gull wing preparation of laminates veneers |
| conventional preparation veneers | Active comparator | intervention: conventional preparation in laminates veneers preparation of veneers without lingual extension of preparation in mesial and distal areas Receives: Procedure: conventional preparation of laminates veneers |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring marginal adaptation of laminates veneers using stero-microscope
marginal adaptation of laminates veneers will be assess as follows, before laminates cementation, an impression material will be placed in the fitting surface of the veneers and placed over the reduced tooth using finger pressure, after material set the impression replica is separated from the laminates and the replica is section and measures under stero-microscope for marginal adaptation, measurement will be performed in eight different points on the buccal and mesio-distal sections, measurement will be in micrometer.
Measured: immediately before laminates delivery up to 4 week sfter tooth preparation
Secondary outcomes (1)
measuring tooth sensitivity after tooth preparation for laminates veneers
measurment will be acording tomodified United States Public Health Service (USPHS) criteria used for the clinical evaluations of the restorations. post-operative sensitivity 0 No symptoms
- Slight sensitivity
- Moderate sensitivity
- Severe pain
Measured: one week after tooth preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start13 Jul 2018 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teeth SensitivityStudies 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
- Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Housham nabiel hassan musa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214549
- Sponsor's protocol ID
- CairoUni
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Adaptation of E.Max Laminate Veneers Prepared With Modified Gull Wing Preparation and Conventional Preparation
- ClinicalTrials.gov ID
- NCT03214549
- Acronym / sponsor ID
- CairoUni
- Conditions
- Teeth Sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Jul 2018 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 11 Jul 2017 (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 is to evaluate tooth sensitivity and marginal adaptation of porcelain laminates veneers prepared with modified gull wing preparation and conventional preparation.
Detailed description
Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radio-graphic examination and primary impression for diagnostic cast construction.
Visit 2: Teeth preparation, secondary impression,temporary restoration and teeth sensitivity evaluation using United States Public Health Service criteria.
Visit 3: Placement and permanent cementation of the final restoration
Visit 4: marginal adaptation measurement by electron microscope using impression replica.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gull wing preparation veneers | Active comparator | Procedure: gull wing preparation of laminates veneersintervention: gull wing preparation in laminates veneers proximal margin of the preparation is placed toward the lingual .The area of the proximal margin between the contact area and the gingival papilla is placed even further to the lingual. This preparation design helps to hide the margin when the restorations are viewed from an angle. |
| conventional preparation veneers | Active comparator | Procedure: conventional preparation of laminates veneersintervention: conventional preparation in laminates veneers preparation of veneers without lingual extension of preparation in mesial and distal areas |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- From 18-40 years old, be able to read and sign the informed consent document.
- Be physically and psychologically able to tolerate conventional restorative Procedures.
- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- Patients with teeth problems indicated for laminate veneer (e.g:discoloration, fracture not involve more than 50% enamel loss, mild malposition.
- Be willing to return for follow-up examinations and evaluation.
Key exclusion criteria (7 listed)
- Patients in the growth stage with partially erupted teeth.
- Patient with fractured teeth of more than 50% enamel loss.
- Patients with poor oral hygiene and motivation.
- Pregnant women.
- Patient with post and core endodontically treated teeth.
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 |
|---|---|---|
| gull wing preparation of laminates veneersAlso: dog leg preparation of laminates veneerspreparation involving mesial and distal extension further lingualy. | Procedure or surgery | gull wing preparation veneers |
| conventional preparation of laminates veneerspreparation not involving mesial and distal extension further lingualy. | Procedure or surgery | conventional preparation veneers |
Primary outcome
measuring marginal adaptation of laminates veneers using stero-microscope
Time frame: immediately before laminates delivery up to 4 week sfter tooth preparation
marginal adaptation of laminates veneers will be assess as follows, before laminates cementation, an impression material will be placed in the fitting surface of the veneers and placed over the reduced tooth using finger pressure, after material set the impression replica is separated from the laminates and the replica is section and measures under stero-microscope for marginal adaptation, measurement will be performed in eight different points on the buccal and mesio-distal sections, measurement will be in micrometer.
1 secondary outcome
measuring tooth sensitivity after tooth preparation for laminates veneers
Time frame: one week after tooth preparation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing gull wing preparation of laminates veneers and conventional preparation of laminates veneers in people with Teeth Sensitivity, run by Cairo University.
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 5 inclusion and 7 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 11 Jul 2017. 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 housham N Musa, master (00201068778033, dr_hishamnabeel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring marginal adaptation of laminates veneers using stero-microscope (time frame: immediately before laminates delivery up to 4 week sfter tooth preparation). 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 11 Jul 2017.