Aesthetic Outcome of Crowns on ImplantsNCT03686267
Evaluation of the Aesthetic Outcome of Lithium Disilicate (e.Max) All Ceramic Crowns on Titanium Implant Abutments in the Aesthetic Zone After Different Color Masking Approaches
A study testing opaqued titanium abutments, lithium disilicate coping (high opacity) and titanium abutment with no color masking in people with Aesthetic Outcome of Crowns on Implants, run by Cairo University at 1 site in Egypt.
Trial summary
Implants have become the perfect solution for replacement of missing single teeth, partial or even complete edentulism.18 However, the dilemma of anterior implant-supported prosthesis is still not quite solved.19-21 Implant abutments are one of the esthetic influencers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Outcome of Crowns on Implants
- What is being tested?
- opaqued titanium abutments, lithium disilicate coping (high opacity) and titanium abutment with no color masking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2019to 28 Sep 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Above 18 years old 2. Literate, capable of reading and signing the informed consent document 3. Healthy, Free from or with controlled systemic disease 4. With acceptable oral health to support implant restorations 5. With good bone quality and quantity 6. Cooperative, accepting follow up and maintenance sessions 7. Having missing tooth in esthetic zone
Who cannot join
- 1. Under 18 years old 2. Illiterate, unable of comprehending or signing the informed consent document 3. Unhealthy with uncontrolled systemic disease (e.g. Diabetes or hypertension) 4. Pregnancy 5. With unfavorable oral state that might affect implant procedure and restoration 6. Uncooperative, not willing to return for follow up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Esthetic Outcome of Lithium Disilicate (e.Max) All Ceramic Crowns on Titanium Implant Abutments in the Esthetic Zone After Different Color Masking Approaches; a Randomized Clinical Trial
Implants have become the perfect solution for replacement of missing single teeth, partial or even complete edentulism.18 However, the dilemma of anterior implant-supported prosthesis is still not quite solved.19-21 Implant abutments are one of the esthetic influencers. And concerning the material, ready-made titanium abutments are considered the gold standard of all. Nevertheless, the esthetic properties remain doubtful. Lithium disilicate ceramics have been used as implant superstructures for many years now for their combined esthetic and biomechanical properties. The purpose of the present study is to evaluate the effect of using titanium implant abutment on the color of lithium disilicate crowns and the significance of masking the titanium abutments with opaque porcelain or using opaque lithium disilicate coping on the final esthetic outcome
Read the detailed description
Clinical resemblance is one the of main factors that preclude the success of any restoration. The use of conventional titanium implant abutment and ceramic restoration succeeded to prevail until now. New ceramic and polymer derivatives have been introduced such as hybrid ceramics, PEEK and PEKK. However, the low mechanical properties and the ease of breakage still limited them to certain clinical situations. Hybrid fixture-abutment combinations such as hybrid abutments and hybrid crowns proved to be highly efficient in the literature. But the technique sensitivity and the urge of high clinical and laboratory skills are obstacles that must be taken into consideration. This is the reason that finding esthetic modification of the conventional techniques seems reasonable. Masking the color of the underlying abutment appears to be a simple and easily achievable solution for having a highly esthetic implant supported prosthesis.
The importance of peri-implant soft tissues, whether esthetically or biologically, has been emphasized in literature. (4) Furthermore, achieving the desired esthetic outcome depends on simultaneously matching the proper esthetic criteria of the tooth and its supporting structures. (5) Esthetic failures in implant dentistry can be categorized as pink-tissue failures and white-tissue failures. (6) Pink esthetics include color, texture and level of peri-implant tissues (7), while white esthetics include color, shape and characterization of crown. (3) The mode of fabrication also influences the performance of the materials, where the use of press technology facilitates the construction of implant supported crowns, offering precision of fit, durability and esthetic materials application. (11)
- Conditions
- Aesthetic Outcome of Crowns on Implants
- Being tested
- opaqued titanium abutments, lithium disilicate coping (high opacity), titanium abutment with no color masking
- Keywords
- implants- titanium abutments- all ceramic crowns- lithium disilicate- color measurements- pink and white aesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opaqued titanium abutmentsOther
masking metallic color of titanium abutments by opaque porcelain
lithium disilicate coping (high opacity)Other
Also called E-max coping
masking metallic color of titanium abutments using lithium disilicate copings
titanium abutment with no color maskingOther
color masking methods are avoided in this arm
| Study group | Role | What they receive |
|---|---|---|
| intervention (I1) | Experimental | Lithium disilicate crowns over titanium abutments covered by a layer of opaque porcelain Receives: Other: opaqued titanium abutments |
| Intervention (I2) | Experimental | Lithium disilicate crowns over titanium abutments covered by lithium disilicate (high opacity) coping Receives: Other: lithium disilicate coping (high opacity) |
| Lithium disilicate crowns over uncovered titanium abutments | Active comparator | Lithium disilicate crowns over uncovered titanium abutments directly without masking Receives: Other: titanium abutment with no color masking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pink esthetics and White esthetics
using numerical score (0-10) to evaluate the aesthetics of soft and hard dental tissues
Measured: six months
Secondary outcomes (1)
Color measurements
using Spectrophotometer to evaluate color in terms of CIE L* a* b* values
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start25 Jul 2019
- Primary completion3 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aesthetic Outcome of Crowns on ImplantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Ahmed Awadallah Osman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686267
- Sponsor's protocol ID
- CEBD-CU-2018-09-26
- Status last verified
- Jun 2025
- First submitted
- 25 Sep 2018
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Esthetic Outcome of Lithium Disilicate (e.Max) All Ceramic Crowns on Titanium Implant Abutments in the Esthetic Zone After Different Color Masking Approaches; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03686267
- Acronym / sponsor ID
- CEBD-CU-2018-09-26
- Conditions
- Aesthetic Outcome of Crowns on Implants
- Keywords
- implants- titanium abutments- all ceramic crowns- lithium disilicate- color measurements- pink and white aesthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- 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.
Implants have become the perfect solution for replacement of missing single teeth, partial or even complete edentulism.18 However, the dilemma of anterior implant-supported prosthesis is still not quite solved.19-21 Implant abutments are one of the esthetic influencers. And concerning the material, ready-made titanium abutments are considered the gold standard of all. Nevertheless, the esthetic properties remain doubtful. Lithium disilicate ceramics have been used as implant superstructures for many years now for their combined esthetic and biomechanical properties. The purpose of the present study is to evaluate the effect of using titanium implant abutment on the color of lithium disilicate crowns and the significance of masking the titanium abutments with opaque porcelain or using opaque lithium disilicate coping on the final esthetic outcome
Detailed description
Clinical resemblance is one the of main factors that preclude the success of any restoration. The use of conventional titanium implant abutment and ceramic restoration succeeded to prevail until now. New ceramic and polymer derivatives have been introduced such as hybrid ceramics, PEEK and PEKK. However, the low mechanical properties and the ease of breakage still limited them to certain clinical situations. Hybrid fixture-abutment combinations such as hybrid abutments and hybrid crowns proved to be highly efficient in the literature. But the technique sensitivity and the urge of high clinical and laboratory skills are obstacles that must be taken into consideration. This is the reason that finding esthetic modification of the conventional techniques seems reasonable. Masking the color of the underlying abutment appears to be a simple and easily achievable solution for having a highly esthetic implant supported prosthesis.
The importance of peri-implant soft tissues, whether esthetically or biologically, has been emphasized in literature. (4) Furthermore, achieving the desired esthetic outcome depends on simultaneously matching the proper esthetic criteria of the tooth and its supporting structures. (5) Esthetic failures in implant dentistry can be categorized as pink-tissue failures and white-tissue failures. (6) Pink esthetics include color, texture and level of peri-implant tissues (7), while white esthetics include color, shape and characterization of crown. (3) The mode of fabrication also influences the performance of the materials, where the use of press technology facilitates the construction of implant supported crowns, offering precision of fit, durability and esthetic materials application. (11)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention (I1) | Experimental | Other: opaqued titanium abutmentsLithium disilicate crowns over titanium abutments covered by a layer of opaque porcelain |
| Intervention (I2) | Experimental | Other: lithium disilicate coping (high opacity)Lithium disilicate crowns over titanium abutments covered by lithium disilicate (high opacity) coping |
| Lithium disilicate crowns over uncovered titanium abutments | Active comparator | Other: titanium abutment with no color maskingLithium disilicate crowns over uncovered titanium abutments directly without masking |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Above 18 years old 2. Literate, capable of reading and signing the informed consent document 3. Healthy, Free from or with controlled systemic disease 4. With acceptable oral health to support implant restorations 5. With good bone quality and quantity 6. Cooperative, accepting follow up and maintenance sessions 7. Having missing tooth in esthetic zone
Key exclusion criteria (1 listed)
- 1. Under 18 years old 2. Illiterate, unable of comprehending or signing the informed consent document 3. Unhealthy with uncontrolled systemic disease (e.g. Diabetes or hypertension) 4. Pregnancy 5. With unfavorable oral state that might affect implant procedure and restoration 6. Uncooperative, not willing to return for follow up visits
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 |
|---|---|---|
| opaqued titanium abutmentsmasking metallic color of titanium abutments by opaque porcelain | Other | intervention (I1) |
| lithium disilicate coping (high opacity)Also: E-max copingmasking metallic color of titanium abutments using lithium disilicate copings | Other | Intervention (I2) |
| titanium abutment with no color maskingcolor masking methods are avoided in this arm | Other | Lithium disilicate crowns over uncovered titanium abutments |
Primary outcome
Pink esthetics and White esthetics
Time frame: six months
using numerical score (0-10) to evaluate the aesthetics of soft and hard dental tissues
1 secondary outcome
Color measurements
Time frame: six 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 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opaqued titanium abutments, lithium disilicate coping (high opacity) and titanium abutment with no color masking in people with Aesthetic Outcome of Crowns on Implants, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pink esthetics and White esthetics (time frame: six 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 13 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.