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

Cairo University (CU)

Status: Completed

Conditions: Prosthesis Survival

Treatments: Other: lithium disilicate glass-ceramic; Other: Vita Enamic (hybrid dental ceramic)

Study type: Interventional

Funder types: Other

Identifiers

NCT02931903

CEBD-CU-2016-10-219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Hybrid superstructure

Experimental group

Description:

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

Treatment:

Other: Vita Enamic (hybrid dental ceramic)

Ceramic superstructure

Active Comparator group

Description:

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

Treatment:

Other: lithium disilicate glass-ceramic