Aesthetic EvaluationNCT02090647
Aesthetic Evaluation of Different Abutment Materials for OsseoSpeed Implants
A study testing aesthetic outcome in people with Aesthetic Evaluation and Implant Survival Rate, run by University of Siena at 1 site in Italy.
Trial summary
The objective of the study was to assess the aesthetic outcome of different abutments materials and shapes on dental implants . A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue , radiographic evaluations and clinical photographs, was used to obtain a measure of the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aesthetic Evaluation, Implant Survival Rate
- What is being tested?
- aesthetic outcome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jan 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged over 18 years
- dental implant rehabilitation requested
- at least 1 tooth missing in areas between 1.5-3.5 and 3.5-4.5
- sufficient bone volume for implant placement ( length 10-15mm; diameter 2.5-4mm, bone quality between class I and III of Lekholm and Zarb).
- informed consensus acceptance
Who cannot join
- systemic pathologies that represent controindication to implantology
- smoking (more than 10 cigarettes per day)
- severe bruxism
- untreated periodontitis
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Dental Materials and Fixed Prosthodontics of the University of Siena, Policlinico Le Scotte
Siena, Siena, 53100
About this study
Official title: Aesthetic Outcome of Osseospeed Implants With Three Different Abutment Materials. A Randomized Controlled Clinical Study
The objective of the study was to assess the aesthetic outcome of different abutments materials and shapes on dental implants .
A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue , radiographic evaluations and clinical photographs, was used to obtain a measure of the aesthetic of implant-prosthesis rehabilitations.
- Conditions
- Aesthetic Evaluation, Implant Survival Rate
- Being tested
- aesthetic outcome
- Keywords
- dental implant, aesthetic, implant abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aesthetic outcomeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| titanium 1 | Active comparator | titanium abutment type 1 Receives: Behavioral: aesthetic outcome |
| titanium 2 | Active comparator | titanium abutment type 2 Receives: Behavioral: aesthetic outcome |
| zirconia 1 | Active comparator | zirconia abutment type 1 Receives: Behavioral: aesthetic outcome |
| zirconia 2 | Active comparator | zirconia abutment type 2 Receives: Behavioral: aesthetic outcome |
| titanium nitrate | Active comparator | titanium nitrate abutment Receives: Behavioral: aesthetic outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
aesthetic evaluation
measure of how the implant-prosthesis restoration is able to comply with the color, shape and proportions imitating as much as possible natural dentition.
Measured: 12 months
Secondary outcomes (1)
implant survival rate
Survival rate means the success rate of the dental implant and/or the restoration that is placed on top of the dental implant.
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 posted18 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aesthetic EvaluationStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Marco Ferrari, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090647
- Sponsor's protocol ID
- ABTM001
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Outcome of Osseospeed Implants With Three Different Abutment Materials. A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02090647
- Acronym / sponsor ID
- ABTM001
- Conditions
- Aesthetic Evaluation, Implant Survival Rate
- Keywords
- dental implant, aesthetic, implant abutment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Mar 2014 (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 objective of the study was to assess the aesthetic outcome of different abutments materials and shapes on dental implants .
A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue , radiographic evaluations and clinical photographs, was used to obtain a measure of the aesthetic of implant-prosthesis rehabilitations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| titanium 1 | Active comparator | Behavioral: aesthetic outcometitanium abutment type 1 |
| titanium 2 | Active comparator | Behavioral: aesthetic outcometitanium abutment type 2 |
| zirconia 1 | Active comparator | Behavioral: aesthetic outcomezirconia abutment type 1 |
| zirconia 2 | Active comparator | Behavioral: aesthetic outcomezirconia abutment type 2 |
| titanium nitrate | Active comparator | Behavioral: aesthetic outcometitanium nitrate abutment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged over 18 years
- dental implant rehabilitation requested
- at least 1 tooth missing in areas between 1.5-3.5 and 3.5-4.5
- sufficient bone volume for implant placement ( length 10-15mm; diameter 2.5-4mm, bone quality between class I and III of Lekholm and Zarb).
- informed consensus acceptance
Key exclusion criteria (4 listed)
- systemic pathologies that represent controindication to implantology
- smoking (more than 10 cigarettes per day)
- severe bruxism
- untreated periodontitis
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 |
|---|---|---|
| aesthetic outcome | Behavioural | titanium 1, titanium 2, titanium nitrate, zirconia 1, zirconia 2 |
Primary outcome
aesthetic evaluation
Time frame: 12 months
measure of how the implant-prosthesis restoration is able to comply with the color, shape and proportions imitating as much as possible natural dentition.
1 secondary outcome
implant survival rate
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 18 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aesthetic outcome in people with Aesthetic Evaluation and Implant Survival Rate, run by University of Siena at 1 site in Italy.
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 5 inclusion and 4 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 18 Mar 2014. 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 Italy. 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?
aesthetic evaluation (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 18 Mar 2014.