Lithium Disilicate Glass-ceramic Versus Hybrid Ceramic Superstructure Materials on Implant Stability

NCT ID: NCT02931903

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-03-31

Brief Summary

The aim of this study is to assess the effect of the newly introduced (hybrid dental ceramic) superstructure materials, Vita Enamic versus IPS Emax on implant stability, patient satisfaction and crestal bone loss.

Detailed Description

This study will be conducted on patients requiring single implant replacement in the maxillary premolar area, admitted to the Outpatient Clinic of Fixed Prosthodontics Department, Faculty of Oral and Dental medicine, Cairo University.

After a period of healing of 6 months, an implant abutment of accurate diameter and angulation will be placed to fit precisely into the internal hex of the fixture after removal of the cover screw. The platform matched abutment will be then secured into its final position using the abutment screw. Alginate impression will be taken and poured into dental stone. Using the impression transfers, impressions with polyvinylsiloxane are taken. After taking the impressions, the Impression transfers are removed and fixed to the implant replica.

Surgeons' assistants will be asked to open the sealed envelope containing the information regarding the crown placement. The impressions will be sent to dental laboratory with the result of the sealed envelope, for preparation of the future crowns, either vita enamic crowns or Ips e max crowns.

Conditions

Prosthesis Survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hybrid superstructure

Vita Enamic is a hybrid ceramic, consisting of composite and ceramic. The ceramic; compatible and high aesthetics while the composite; resilient material with low modulus of elasticity which will absorb stress and therefore decrease load on bone and eventually decrease crestal bone loss

Group Type: EXPERIMENTAL

Vita Enamic (hybrid dental ceramic)

Intervention Type: OTHER

Vita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology,

Ceramic superstructure

IPS Emax, is the mostly used ceramic superstructures in implant supported restorations.

Group Type: ACTIVE_COMPARATOR

lithium disilicate glass-ceramic

Intervention Type: OTHER

All ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology

Interventions

Vita Enamic (hybrid dental ceramic)

Vita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology,

Intervention Type: OTHER

lithium disilicate glass-ceramic

All ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology

Intervention Type: OTHER

Other Intervention Names

hybrid, resin nanoceramic; Emax CAD, IPS Emax

Eligibility Criteria

Inclusion Criteria

Patients > 18 yrs. Patients with missing teeth in the maxillary premolar region. Absence of any pathological condition in the recipient site.

Stabilization phase will be performed including:

• Scaling
• Debridement.
• Elimination of all carious cavities and root canal treatment if needed.
• Elimination of over-hanging restoration. Systemic condition of the subjects was evaluated according to dental modification of the Cornell medical index (Kerr and Millard 1966).

Patients who are cooperative, motivated, and hygiene conscious. Patients should have adequate ridge width (>5mm).

Exclusion Criteria

Patients unable to undergo minor surgical procedure. Patients with history of drug abuse or metabolic drugs. Patients with history of psychiatric disorder. Patients with insufficient bone. Patients with insufficient vertical inter-arch space, upon centric occlusion, to accommodate the available restorative components.

Patients with any systemic condition that may contraindicate implant therapy. Patients that may have any habits that may jeopardize the osseo-integration process, such as heavy smoking and alcoholism.

Patients with para-functional habits that produce overload on the implant such as bruxism and clenching.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sally Edward Fekry

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gihan El Naggar, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Other Identifiers

CEBD-CU-2016-10-219

Identifier Type: -

Identifier Source: org_study_id