Single Tooth Dental ImplantNCT02937220
Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
A study testing monolithic zirconia crown and metal ceramic crown in people with Single Tooth Dental Implant, run by Cairo University.
Trial summary
The aim of this study is to evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Tooth Dental Implant
- What is being tested?
- monolithic zirconia crown and metal ceramic crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients above 18 years old.
- Patients able to read and sign the informed consent document. 3. Medically free patients or with controlled systemic disease.
- 4. Patients with good bone quality and quantity evaluated using C.B.C.T. 5. Patients willing to return for follow-up examinations and evaluation. 6. Patients having single missing recently extracted premolar tooth.
Who cannot join
- Young patients in growth stage.
- Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
- Pregnant women to avoid any complication that may occur in dental office.
- Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
- Psychiatric problems or unrealistic expectations.
- Multiple adjacent missing teeth.
- Patients with bad oral hygiene
About this study
The aim of this study is to evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone.
Read the detailed description
The transfer of occlusal forces to the implant bone interface greatly influence the long term prognosis of implants and crestal bone resorption. Accordingly this study will investigate the influence of metal ceramic crowns and monolithic zirconia crowns on crestal bone resorption under loading. Also these crown materials greatly influence the final aesthetic outcome of the definitive restoration, which will be evaluated using the pink and white aesthetic scoring systems.
- Conditions
- Single Tooth Dental Implant
- Being tested
- monolithic zirconia crown, metal ceramic crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monolithic zirconia crownProcedure or surgery
New crown material used as final restoration for dental implants
metal ceramic crownProcedure or surgery
Conventional crown material used as final restoration for dental implants
| Study group | Role | What they receive |
|---|---|---|
| Monolithic zirconia crowns | Experimental | New crown material to restore dental implants Receives: Procedure: monolithic zirconia crown |
| metal ceramic crowns | Active comparator | conventional crown material for restoring dental implants Receives: Procedure: metal ceramic crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
P.E.S.
Pink aesthetic scoring system for soft tissue aesthetics
Measured: 1 year
Secondary outcomes (1)
crestal bone resorption
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Tooth Dental ImplantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Roshdy Radwan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937220
- Sponsor's protocol ID
- CEBD-CU-2016-10-223
- Status last verified
- Oct 2016
- First submitted
- 16 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
- ClinicalTrials.gov ID
- NCT02937220
- Acronym / sponsor ID
- CEBD-CU-2016-10-223
- Conditions
- Single Tooth Dental Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 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 evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone.
Detailed description
The transfer of occlusal forces to the implant bone interface greatly influence the long term prognosis of implants and crestal bone resorption. Accordingly this study will investigate the influence of metal ceramic crowns and monolithic zirconia crowns on crestal bone resorption under loading. Also these crown materials greatly influence the final aesthetic outcome of the definitive restoration, which will be evaluated using the pink and white aesthetic scoring systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monolithic zirconia crowns | Experimental | Procedure: monolithic zirconia crownNew crown material to restore dental implants |
| metal ceramic crowns | Active comparator | Procedure: metal ceramic crownconventional crown material for restoring dental implants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients above 18 years old.
- Patients able to read and sign the informed consent document. 3. Medically free patients or with controlled systemic disease.
- 4. Patients with good bone quality and quantity evaluated using C.B.C.T. 5. Patients willing to return for follow-up examinations and evaluation. 6. Patients having single missing recently extracted premolar tooth.
Key exclusion criteria (7 listed)
- Young patients in growth stage.
- Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
- Pregnant women to avoid any complication that may occur in dental office.
- Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
- Psychiatric problems or unrealistic expectations.
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 |
|---|---|---|
| monolithic zirconia crownNew crown material used as final restoration for dental implants | Procedure or surgery | Monolithic zirconia crowns |
| metal ceramic crownConventional crown material used as final restoration for dental implants | Procedure or surgery | metal ceramic crowns |
Primary outcome
P.E.S.
Time frame: 1 year
Pink aesthetic scoring system for soft tissue aesthetics
1 secondary outcome
crestal bone resorption
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing monolithic zirconia crown and metal ceramic crown in people with Single Tooth Dental Implant, 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Oct 2016. 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?
Results are not available in the source record.
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?
P.E.S. (time frame: 1 year). 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 18 Oct 2016.