A Clinical Trial of the Impact of Speed and Conventional Sintering on Ultra-thin, Highly Translucent, Multilayered Zirconia Laminate Restorations

NCT05751616 | Unknown

• 1 other identifier: TP_22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A Minimally invasive esthetic restorative approach with the advancement of highly translucent multilayered monolithic zirconia ceramic can provide minimal thickness that affords high strength and esthetics without the need for layering porcelain. The effect of sintering conditions on yttria-partially stabilized zirconia is essential for the long-term success of such restorations. The study aims to evaluate the clinical performance of speed and conventional sintering on ultra-thin, highly translucent, multilayered zirconia laminate restorations with minimum invasive tooth preparation.

Conditions

Dental Veneers

Outcome Measures

Primary Outcomes (1)

• Change in clinical performance

  Patients will be recalled every 3 months for one year follow up. The clinical evaluation and color measurement will be based on the modified California Dental Association (CDA)/Ryge criteria of evaluation as shown Examiners will evaluate the zirconia Veneers for the following: 1. Color match. 2. Zirconia surface. 3. Marginal discoloration. 4. Marginal integrity. 5. Clinical evaluation of the completed restorations will be performed using a double-blind assessment method

  Baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (2)

Conventional sintering

ACTIVE COMPARATOR

Other: Laminate veneers with conventional sintering

Speed sintering

EXPERIMENTAL

Other: Laminate veneers with speed sintering

Interventions

Laminate veneers with speed sintering OTHER

Zirconia specimens will be sintered using speed sintering cycle in a conventional furnace according to the manufacturer instructions.

Speed sintering

Laminate veneers with conventional sintering OTHER

Zirconia specimens will be sintered using conventional sintering cycle in a conventional furnace according to the manufacturer instructions.

Conventional sintering

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients able to understand and sign the informed consent form.
• physically and psychologically able to undergo conventional restorative procedures.
• Good oral hygiene with no signs of periapical pathology or periodontal disease. (periodontal screening index 0-1).
• Slight malposition.
• Teeth with spacing.
• Teeth with discoloration.
• Patient having natural teeth as opposing dentition

You may not qualify if:

• Insufficient surface enamel (60%).
• Abutments with subgingival restorations or root caries.
• Parafunctional habits.
• Lack of opposite occluding dentition in the area intended for restoration.
• mandibular prognathism and maxillary retrognathism

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

RECRUITING

Central Study Contacts

Mahinour A El Moniem, Msc

CONTACT

01060080088; Dr.Mahinour_Ahmed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: February 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

EG (1)