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Status unknownNCT05114122vonlay-onlayUpdated Nov 9, 2021

Clinical Outcomes of Premolars Restored With Ceramic Vonlay Restorations Versus Onlay Using Modified USPHS Criteria

An interventional study of Vonlay Ceramic restorations and Onlay Ceramic restorations in Clinical Performance of Ceramic Vonlays, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 25 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-09.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2021, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
25 Years to 44 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Clinical Performance of Ceramic Vonlays

Keywords

  • Ceramics, vonlay, onlay, fracture
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
26 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureVonlay 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

    Also known as: Onlay ceramic restorations with buccal veneer

  • ProcedureOnlay 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

06

What researchers measure

Primary outcomes

  1. Fracture

    assessed according to modified USPHS criteria (Alpha, Bravo)

    Time frame: change from baseline at 3,6,9,12 months

Secondary outcomes

  1. Marginal integrity

    assessed according to modified USPHS criteria (Alpha, Bravo, Charlie and Delta)

    Time frame: 0,3,6,9,12 months

  2. Marginal discoloration

    assessed according to modified USPHS criteria (Alpha, Bravo and Charlie)

    Time frame: 0,3,6,9,12 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Dentistry, Cairo University, 11 El-Saraya St. El Manial
    Cairo, El Manial, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05114122
Lead sponsor
Cairo University
Responsible party
Mohamed Abdel Aziz Hazzaa (Principal Investigator, Cairo University) — Principal investigator
First posted
Nov 9, 2021
Start date
Jan 1, 2021
Primary completion
Dec 2021 (estimated)
Completion
Jan 2022 (estimated)
Last update
Nov 9, 2021

Study contacts

Mohamed Abdel Aziz Hazzaa, PHD
Contact
mohamed.hazzaa@dentistry.cu.edu.eg
00201066599505
Mohamed Abdel Aziz Hazzaa, PHD
Contact
mohazza3@gmail.com
00201116545475

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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