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

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: Recruiting
• Conditions: Clinical Performance of Ceramic Vonlays
• Intervention / Treatment: Procedure: Vonlay Ceramic restorations; Procedure: Onlay Ceramic restorations

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: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Abdel Aziz Hazzaa, PHD; Phone Number: 00201066599505; Email: mohamed.hazzaa@dentistry.cu.edu.eg
• 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: Mohamed Abdel Aziz Hazzaa, PHD; Phone Number: 00201066599505; Email: mohamed.hazzaa@dentistry.cu.edu.eg
      • Contact: Mohamed Abdel Aziz Hazzaa, PHD; Phone Number: 00201116545475; Email: mohazza3@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Fracture	assessed according to modified USPHS criteria (Alpha, Bravo)	change from baseline at 3,6,9,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal integrity	assessed according to modified USPHS criteria (Alpha, Bravo, Charlie and Delta)	0,3,6,9,12 months
Marginal discoloration	assessed according to modified USPHS criteria (Alpha, Bravo and Charlie)	0,3,6,9,12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 6, 2021
• First Posted (ACTUAL): November 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 6, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Ceramics, vonlay, onlay, fracture
• Other Study ID 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