NCT02931903

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

October 11, 2016

Last Update Submit

January 10, 2023

Conditions

Prosthesis Survival

Keywords

implant supported restorationsIPS Emax (lithium disilicate glass-ceramic)Vita Enamic (hybrid dental ceramic)implant survivalperi-implant tissue response

Outcome Measures

Primary Outcomes (1)

  • Implant survival rate

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

    12 months

Secondary Outcomes (3)

  • Crestal bone loss

    12 months

  • Peri-implant tissue response

    12 months

  • Patient satisfaction

    12 months

Study Arms (2)

Hybrid superstructure

EXPERIMENTAL

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

Other: Vita Enamic (hybrid dental ceramic)

Ceramic superstructure

ACTIVE COMPARATOR

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

Other: lithium disilicate glass-ceramic

Interventions

Vita Enamic (hybrid dental ceramic)OTHER

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

Also known as: hybrid, resin nanoceramic
Hybrid superstructure
lithium disilicate glass-ceramicOTHER

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

Also known as: Emax CAD, IPS Emax
Ceramic superstructure

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prosthesis Failure

Interventions

VITA Enamic

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gihan El Naggar, Professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 13, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share