Prosthesis SurvivalRCTNCT02931903
Lithium Disilicate Glass-ceramic Versus Hybrid Ceramic Superstructure Materials on Implant Stability
A study testing Vita Enamic (hybrid dental ceramic) and lithium disilicate glass-ceramic in people with Prosthesis Survival, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis Survival
- What is being tested?
- Vita Enamic (hybrid dental ceramic) and lithium disilicate glass-ceramic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: The Effect of Lithium Disilicate Glass-ceramic (IPS Emax) Versus Hybrid Ceramic (Vita Enamic) Superstructure Materials on Implant Stability in Implant Supported Restorations
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.
Read the 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
- Being tested
- Vita Enamic (hybrid dental ceramic), lithium disilicate glass-ceramic
- Keywords
- implant supported restorations, IPS Emax (lithium disilicate glass-ceramic), Vita Enamic (hybrid dental ceramic), implant survival, peri-implant tissue response
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vita Enamic (hybrid dental ceramic)Other
Also called hybrid, resin nanoceramic
Vita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology,
lithium disilicate glass-ceramicOther
Also called Emax CAD, IPS Emax
All ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Vita Enamic (hybrid dental ceramic) |
| Ceramic superstructure | Active comparator | IPS Emax, is the mostly used ceramic superstructures in implant supported restorations. Receives: Other: lithium disilicate glass-ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
Implant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate
Measured: 12 months
Secondary outcomes (3)
Crestal bone loss
Crestal 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
Measured: 12 months
Peri-implant tissue response
Bleeding index, probing depth and gingival index
Measured: 12 months
Patient satisfaction
Patients will be asked to answer a questionnaire to know whether the procedure was not satisfied, accepted, or highly satisfied
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis SurvivalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Edward Fekry, Cairo University
- Investigators
- Gihan El Naggar, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931903
- Sponsor's protocol ID
- CEBD-CU-2016-10-219
- Acronym
- RCT
- Status last verified
- Jan 2023
- First submitted
- 11 Oct 2016
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lithium Disilicate Glass-ceramic (IPS Emax) Versus Hybrid Ceramic (Vita Enamic) Superstructure Materials on Implant Stability in Implant Supported Restorations
- ClinicalTrials.gov ID
- NCT02931903
- Acronym / sponsor ID
- RCT / CEBD-CU-2016-10-219
- Conditions
- Prosthesis Survival
- Keywords
- implant supported restorations, IPS Emax (lithium disilicate glass-ceramic), Vita Enamic (hybrid dental ceramic), implant survival, peri-implant tissue response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid superstructure | Experimental | Other: Vita Enamic (hybrid dental ceramic)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 |
| Ceramic superstructure | Active comparator | Other: lithium disilicate glass-ceramicIPS Emax, is the mostly used ceramic superstructures in implant supported restorations. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients > 18 yrs. Patients with missing teeth in the maxillary premolar region. Absence of any pathological condition in the recipient site.
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vita Enamic (hybrid dental ceramic)Also: hybrid, resin nanoceramicVita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology, | Other | Hybrid superstructure |
| lithium disilicate glass-ceramicAlso: Emax CAD, IPS EmaxAll ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology | Other | Ceramic superstructure |
Primary outcome
Implant survival rate
Time frame: 12 months
Implant stability and success could be affected by crestal bone loss, if the implant is stable therefore high survival rate
3 secondary outcomes
Crestal bone loss
Time frame: 12 months
Peri-implant tissue response
Time frame: 12 months
Patient satisfaction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Prosthesis Survival
RecruitingObservational study
Multicenter Mpact DM France
Total Hip Arthroplasty, Survival, Prosthesis
Active, not recruiting
Survivorship of Attune Primary Total Knee Prosthesis
Noninflammatory Degenerative Joint Disease
Active, not recruitingObservational study
Survival of Implant-Supported All-Ceramic Prostheses
Partial Edentulism, Disorder of Prostheses and Implants
Active, not recruitingObservational study
Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.
Peri Implant Mucositis, Peri Implant Bone Loss
Active, not recruitingObservational study
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gihan El Naggar, Professor principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Vita Enamic (hybrid dental ceramic) and lithium disilicate glass-ceramic in people with Prosthesis Survival, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.