Clinical Performance of Ceramic Vonlaysvonlay-onlayNCT05114122
Clinical Outcomes of Premolars Restored With Ceramic Vonlay Restorations Versus Onlay Using Modified USPHS Criteria
A study testing Vonlay Ceramic restorations and Onlay Ceramic restorations in people with Clinical Performance of Ceramic Vonlays, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation the clinical performance of premolars restored with ceramic vonlays versus onlays using modified USPHS criteria after follow-up period of 0,3,6,9,12 months Read more about this study
- Who is it for?
- Ages 25 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Performance of Ceramic Vonlays
- What is being tested?
- Vonlay Ceramic restorations and Onlay Ceramic restorations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to Jan 2022
- 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 25 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range of the patients from 25-44 years old, who could read understand and write to sign the consent by himself /herself
- Have no active periodontal or pulpal diseases, have teeth with good restorations.(19)
- Psychologically and physically able to withstand conventional dental procedures
- Patients with teeth problems indicated for onlay and vonlay (premolars).
- Decayed teeth.
- Teeth restored with large filling restorations.
- Able to return for follow-up examinations and evaluation.
Who cannot join
- Patient less than 25 or more than 44 years.
- Patient with active resistant periodontal diseases.
- Patients with poor oral hygiene, high caries risk and uncooperative patients.
- Pregnant women.
- Patients in the growth stage with partially erupted teeth.
- Psychiatric problems or unrealistic expectations.
- Lack of opposing dentition in the area of interest. 8- The presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University, 11 El-Saraya St. El Manial
Cairo, El Manial
Mohamed Abdel Aziz Hazzaa, PHD, 00201066599505, mohamed.hazzaa@dentistry.cu.edu.eg
Mohamed Abdel Aziz Hazzaa, PHD, 00201116545475, mohazza3@gmail.com
About this study
Official title: Clinical Outcomes of Premolars Restored With Ceramic Vonlay Restorations Versus Onlay Using Modified USPHS Criteria (Randomized Clinical Trial)
Evaluation the clinical performance of premolars restored with ceramic vonlays versus onlays using modified USPHS criteria after follow-up period of 0,3,6,9,12 months
Read the detailed description
two groups of patients with vital premolars indicated for fixed restorations will be selected according to special inclusion criteria (n=13) in each group (total of 26). one group will receive minimally invasive cavity preparations for posterior indirect restorations either vonlay or onlay according to each group the patient will be assessed using Modified USPHS Criteria at 0,3,6,9,12 months regarding fracture, marginal integrity and marginal discoloration
- Conditions
- Clinical Performance of Ceramic Vonlays
- Being tested
- Vonlay Ceramic restorations, Onlay Ceramic restorations
- Keywords
- Ceramics, vonlay, onlay, fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonlay Ceramic restorationsProcedure or surgery
Also called Onlay ceramic restorations with buccal veneer
vonlay is a hybrid of an onlay with an extended buccal veneer surface for use in bicuspid regions where there is mostly enamel to bond to. The vonlay is less invasive, more readily repairable, less technique-sensitive to attain adequate bonding, and will leave sounder tooth structure remaining if further treatment is required in the future
Onlay Ceramic restorationsProcedure or surgery
Onlays are used to restore large areas of decay and also used to replace old restorations, whether they are defective amalgam fillings, old cast-gold onlays, or fabricated from some other material
| Study group | Role | What they receive |
|---|---|---|
| Vonlay lithium disilicate ceramic restorations | Experimental | Vonlay is a hybrid of an onlay with an extended buccal veneer surface for use in bicuspid regions where there is mostly enamel to bond to. The vonlay is less invasive, more readily repairable, less technique-sensitive to attain adequate bonding, and will leave sounder tooth structure remaining if further treatment is required in the future Receives: Procedure: Vonlay Ceramic restorations |
| Onlay lithium disilicate ceramic restorations | Active comparator | Onlays are used to restore large areas of decay and also used to replace old restorations, whether they are defective amalgam fillings, old cast-gold onlays, or fabricated from some other material Receives: Procedure: Onlay Ceramic restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
assessed according to modified USPHS criteria (Alpha, Bravo)
Measured: change from baseline at 3,6,9,12 months
Secondary outcomes (2)
Marginal integrity
assessed according to modified USPHS criteria (Alpha, Bravo, Charlie and Delta)
Measured: 0,3,6,9,12 months
Marginal discoloration
assessed according to modified USPHS criteria (Alpha, Bravo and Charlie)
Measured: 0,3,6,9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Performance of Ceramic VonlaysStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel Aziz Hazzaa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114122
- Sponsor's protocol ID
- CEBD-CU-27-10-2020
- Acronym
- vonlay-onlay
- Status last verified
- Nov 2021
- First submitted
- 27 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Premolars Restored With Ceramic Vonlay Restorations Versus Onlay Using Modified USPHS Criteria (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05114122
- Acronym / sponsor ID
- vonlay-onlay / CEBD-CU-27-10-2020
- Conditions
- Clinical Performance of Ceramic Vonlays
- Keywords
- Ceramics, vonlay, onlay, fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 Nov 2021 (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.
Evaluation the clinical performance of premolars restored with ceramic vonlays versus onlays using modified USPHS criteria after follow-up period of 0,3,6,9,12 months
Detailed description
two groups of patients with vital premolars indicated for fixed restorations will be selected according to special inclusion criteria (n=13) in each group (total of 26). one group will receive minimally invasive cavity preparations for posterior indirect restorations either vonlay or onlay according to each group the patient will be assessed using Modified USPHS Criteria at 0,3,6,9,12 months regarding fracture, marginal integrity and marginal discoloration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonlay lithium disilicate ceramic restorations | Experimental | Procedure: Vonlay Ceramic restorationsVonlay is a hybrid of an onlay with an extended buccal veneer surface for use in bicuspid regions where there is mostly enamel to bond to. The vonlay is less invasive, more readily repairable, less technique-sensitive to attain adequate bonding, and will leave sounder tooth structure remaining if further treatment is required in the future |
| Onlay lithium disilicate ceramic restorations | Active comparator | Procedure: Onlay Ceramic restorationsOnlays are used to restore large areas of decay and also used to replace old restorations, whether they are defective amalgam fillings, old cast-gold onlays, or fabricated from some other material |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age range of the patients from 25-44 years old, who could read understand and write to sign the consent by himself /herself
- Have no active periodontal or pulpal diseases, have teeth with good restorations.(19)
- Psychologically and physically able to withstand conventional dental procedures
- Patients with teeth problems indicated for onlay and vonlay (premolars).
- Able to return for follow-up examinations and evaluation.
Key exclusion criteria (7 listed)
- Patient less than 25 or more than 44 years.
- Patient with active resistant periodontal diseases.
- Patients with poor oral hygiene, high caries risk and uncooperative patients.
- Pregnant women.
- Patients in the growth stage with partially erupted 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 |
|---|---|---|
| Vonlay Ceramic restorationsAlso: Onlay ceramic restorations with buccal veneervonlay is a hybrid of an onlay with an extended buccal veneer surface for use in bicuspid regions where there is mostly enamel to bond to. The vonlay is less invasive, more readily repairable, less technique-sensitive to attain adequate bonding, and will leave sounder tooth structure remaining if further treatment is required in the future | Procedure or surgery | Vonlay lithium disilicate ceramic restorations |
| Onlay Ceramic restorationsOnlays are used to restore large areas of decay and also used to replace old restorations, whether they are defective amalgam fillings, old cast-gold onlays, or fabricated from some other material | Procedure or surgery | Onlay lithium disilicate ceramic restorations |
Primary outcome
Fracture
Time frame: change from baseline at 3,6,9,12 months
assessed according to modified USPHS criteria (Alpha, Bravo)
2 secondary outcomes
Marginal integrity
Time frame: 0,3,6,9,12 months
Marginal discoloration
Time frame: 0,3,6,9,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vonlay Ceramic restorations and Onlay Ceramic restorations in people with Clinical Performance of Ceramic Vonlays, 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 7 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 9 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdel Aziz Hazzaa, PHD (00201066599505, mohamed.hazzaa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture (time frame: change from baseline at 3,6,9,12 months). 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 9 Nov 2021.