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

The Effect of Lithium Disilicate Glass-ceramic (IPS Emax) Versus Hybrid Ceramic (Vita Enamic) Superstructure Materials on Implant Stability in Implant Supported Restorations

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02931903
Acronym
RCT
Enrollment
20
Registered
2016-10-13
Start date
2017-01-31
Completion date
2018-03-31
Last updated
2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthesis Survival

Keywords

implant supported restorations, IPS Emax (lithium disilicate glass-ceramic), Vita Enamic (hybrid dental ceramic), implant survival, peri-implant tissue response

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.

Interventions

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

OTHERlithium disilicate glass-ceramic

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Implant survival rate12 monthsImplant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate

Secondary

MeasureTime frameDescription
Crestal bone loss12 monthsCrestal bone loss will be measured using a Cone Beam Computed tomography to measure the amount of bone resorbed from start date, and follow up for one year
Peri-implant tissue response12 monthsBleeding index, probing depth and gingival index
Patient satisfaction12 monthsPatients will be asked to answer a questionnaire to know whether the procedure was not satisfied, accepted, or highly satisfied

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026