Clinical Outcomes of Premolars Restored With Ceramic Vonlay Restorations Versus Onlay Using Modified USPHS Criteria (vonlay-onlay)

November 6, 2021 updated by: Mohamed Abdel Aziz Hazzaa, Cairo University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Mohamed Abdel Aziz Hazzaa, PHD
  • Phone Number: 00201116545475
  • Email: mohazza3@gmail.com

Study Locations

  • Egypt
    • El Manial
      • Cairo, El Manial, Egypt
        • Recruiting
        • Faculty of Dentistry, Cairo University, 11 El-Saraya St. El Manial
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age range of the patients from 25-44 years old, who could read understand and write to sign the consent by himself /herself
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations.(19)
  3. Psychologically and physically able to withstand conventional dental procedures

  4. Patients with teeth problems indicated for onlay and vonlay (premolars).

    1. Decayed teeth.
    2. Teeth restored with large filling restorations.
  5. Able to return for follow-up examinations and evaluation.

Exclusion Criteria:

  1. Patient less than 25 or more than 44 years.
  2. Patient with active resistant periodontal diseases.
  3. Patients with poor oral hygiene, high caries risk and uncooperative patients.
  4. Pregnant women.
  5. Patients in the growth stage with partially erupted teeth.
  6. Psychiatric problems or unrealistic expectations.
  7. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Vonlay lithium disilicate ceramic restorations
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
Procedure: Vonlay Ceramic restorations
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
Other Names:
  • Onlay ceramic restorations with buccal veneer
ACTIVE_COMPARATOR: Onlay lithium disilicate ceramic restorations
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
Procedure: Onlay Ceramic restorations
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fracture
Time Frame: change from baseline at 3,6,9,12 months
assessed according to modified USPHS criteria (Alpha, Bravo)
change from baseline at 3,6,9,12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Marginal integrity
Time Frame: 0,3,6,9,12 months
assessed according to modified USPHS criteria (Alpha, Bravo, Charlie and Delta)
0,3,6,9,12 months
Marginal discoloration
Time Frame: 0,3,6,9,12 months
assessed according to modified USPHS criteria (Alpha, Bravo and Charlie)
0,3,6,9,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEBD-CU-27-10-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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