Thick Gingival Margin to Tooth RestorationPhase 2NCT02315794
Aesthetic Outcomes of Single Tooth Implant Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments
A Phase 2 study testing SPI®ART and SPI®EASY in people with Thick Gingival Margin to Tooth Restoration, run by University of Firenze and Siena, Napoli, Italy at 2 sites in Italy.
Trial summary
Different studies have proposed the use of zirconia abutments to improve the aesthetic outcomes in the anterior sextant, however the results have been inconclusive. A tendency towards a better aesthetic result with the use of zirconia instead of titanium abutments was observed, although more technical complications… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thick Gingival Margin to Tooth Restoration
- What is being tested?
- SPI®ART and SPI®EASY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesItaly
- Study dates
- Sep 2009to Feb 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mono-edentulism condition in the aesthetic zone
- minimum of 2 mm of keratinized gingiva
Who cannot join
- systemic diseases
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
Siena, Siena, 53100
Tuscan School of Dentistry
Siena, Siena, 53100
About this study
Official title: Aesthetic Outcomes of Single Tooth Implant-supported Restorations Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study
Different studies have proposed the use of zirconia abutments to improve the aesthetic outcomes in the anterior sextant, however the results have been inconclusive. A tendency towards a better aesthetic result with the use of zirconia instead of titanium abutments was observed, although more technical complications were also recorded.The use of zirconia abutments in the anterior maxillary region showed a tendency towards better matching, although differences were not significant. In addition, with these abutments more technical complications were observed, what increased the cost and time. More studies with larger samples and longer observations periods are needed to recommend the use of zirconia abutments for this clinical situation
Read the detailed description
The purpose of the present study was to evaluate the clinical and aesthetic outcomes of single tooth implant restorations, where different abutment materials were used (zirconia vs titanium) associated with metal-ceramic crowns. The evaluation was carried out by means of an aesthetic composite index combined with patient evaluation
- Being tested
- SPI®ART, SPI®EASY
- Keywords
- aesthetic outcome, titanium abutment, zirconia abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI®ARTDevice
implant prothetic restoration using a yttrium oxide stabilized zirconia abutment
SPI®EASYDevice
implant prosthetic restoration using a commercially pure titanium grade 4 abutment
| Study group | Role | What they receive |
|---|---|---|
| SPI®ART | Experimental | in test group after a three month healing period a zirconia abutment was connected to the implant to realize the prosthetic restoration Receives: Device: SPI®ART |
| SPI®EASY | Active comparator | in control group a three month healing period a titanium abutment was connected to the implant for the prosthetic restoration Receives: Device: SPI®EASY |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in the anatomic form and surface characteristics of the peri implant mucosa
the following parameters were assessed by means of standardized photographs: contour of the labial surface of the mucosa and its colour; when compared to the adjacent teeth , penalty points were assigned ( 0 = excellent; 1 or 2 = satisfactory; 3 or 4 = moderate; 5 ore more, poor).
Measured: one month and one year after the placement of the definitive crowns
Secondary outcomes (3)
change from baseline in crestal bone levels
in standardized intraoral radiographs the the following measurements were carried out : vertical distance from implant shoulder to the most coronal bone in contact with the implant at mesial and distal site; horizontal distance from the implant shoulder to the adjacent teeth at mesial and distal sites; vertical distance ( parallel to the implant long axis) from the contact point to the bone crest at mesial and distal sides
Measured: one month and one year after placing the definitive crown
change from baseline in interdental soft tissue position
position of interdental papilla measured by means of Papilla Index ( Jemt, 1997)
Measured: one month and one year after the placement of the definitive crowns
change from baseline in thickness of the peri implant mucosa
the thickness was measured by placing a calibrated endodontic file 2mm apical to the mucosal margin
Measured: one month and one year after the placement of the definitive crowns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thick Gingival Margin to Tooth RestorationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Firenze and Siena, Napoli, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nicola baldini, University of Firenze and Siena, Napoli, Italy
- Investigators
- nicola baldini, oral surgeon, Principal investigator, tuscal school of dental medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315794
- Sponsor's protocol ID
- aostirct
- Status last verified
- Dec 2014
- First submitted
- 6 Dec 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Meijer HJ, Stellingsma K, Meijndert L, Raghoebar GM. A new index for rating aesthetics of implant-supported single crowns and adjacent soft tissues--the Implant Crown Aesthetic Index. Clin Oral Implants Res. 2005 Dec;16(6):645-9. doi: 10.1111/j.1600-0501.2005.01128.x.
PubMed 16307570Ferrantino L, Carrillo de Albornoz A, Sanz M. Five-year outcomes of a randomized controlled clinical trial comparing single-tooth implant-supported restoration with either zirconia or titanium abutments. J Clin Periodontol. 2023 Jun;50(6):744-754. doi: 10.1111/jcpe.13787. Epub 2023 Feb 28.
PubMed 36748305
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Outcomes of Single Tooth Implant-supported Restorations Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02315794
- Acronym / sponsor ID
- aostirct
- Keywords
- aesthetic outcome, titanium abutment, zirconia abutment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Firenze and Siena, Napoli, ItalyUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Dec 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.
Different studies have proposed the use of zirconia abutments to improve the aesthetic outcomes in the anterior sextant, however the results have been inconclusive. A tendency towards a better aesthetic result with the use of zirconia instead of titanium abutments was observed, although more technical complications were also recorded.The use of zirconia abutments in the anterior maxillary region showed a tendency towards better matching, although differences were not significant. In addition, with these abutments more technical complications were observed, what increased the cost and time. More studies with larger samples and longer observations periods are needed to recommend the use of zirconia abutments for this clinical situation
Detailed description
The purpose of the present study was to evaluate the clinical and aesthetic outcomes of single tooth implant restorations, where different abutment materials were used (zirconia vs titanium) associated with metal-ceramic crowns. The evaluation was carried out by means of an aesthetic composite index combined with patient evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPI®ART | Experimental | Device: SPI®ARTin test group after a three month healing period a zirconia abutment was connected to the implant to realize the prosthetic restoration |
| SPI®EASY | Active comparator | Device: SPI®EASYin control group a three month healing period a titanium abutment was connected to the implant for the prosthetic restoration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mono-edentulism condition in the aesthetic zone
- minimum of 2 mm of keratinized gingiva
Key exclusion criteria (1 listed)
- systemic diseases
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 |
|---|---|---|
| SPI®ARTimplant prothetic restoration using a yttrium oxide stabilized zirconia abutment | Device | SPI®ART |
| SPI®EASYimplant prosthetic restoration using a commercially pure titanium grade 4 abutment | Device | SPI®EASY |
Primary outcome
change from baseline in the anatomic form and surface characteristics of the peri implant mucosa
Time frame: one month and one year after the placement of the definitive crowns
the following parameters were assessed by means of standardized photographs: contour of the labial surface of the mucosa and its colour; when compared to the adjacent teeth , penalty points were assigned ( 0 = excellent; 1 or 2 = satisfactory; 3 or 4 = moderate; 5 ore more, poor).
3 secondary outcomes
change from baseline in crestal bone levels
Time frame: one month and one year after placing the definitive crown
change from baseline in interdental soft tissue position
Time frame: one month and one year after the placement of the definitive crowns
change from baseline in thickness of the peri implant mucosa
Time frame: one month and one year after the placement of the definitive crowns
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 12 Dec 2014.
- Background: PubMed 16307570Meijer HJ, Stellingsma K, Meijndert L, Raghoebar GM. A new index for rating aesthetics of implant-supported single crowns and adjacent soft tissues--the Implant Crown Aesthetic Index. Clin Oral Implants Res. 2005 Dec;16(6):645-9. doi: 10.1111/j.1600-0501.2005.01128.x.
- Derived from this study: PubMed 36748305Ferrantino L, Carrillo de Albornoz A, Sanz M. Five-year outcomes of a randomized controlled clinical trial comparing single-tooth implant-supported restoration with either zirconia or titanium abutments. J Clin Periodontol. 2023 Jun;50(6):744-754. doi: 10.1111/jcpe.13787. Epub 2023 Feb 28.
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.
nicola baldini, oral surgeon principal investigator
tuscal school of dental medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPI®ART and SPI®EASY in people with Thick Gingival Margin to Tooth Restoration, run by University of Firenze and Siena, Napoli, Italy at 2 sites 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 2 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 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change from baseline in the anatomic form and surface characteristics of the peri implant mucosa (time frame: one month and one year after the placement of the definitive crowns). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02315794, which also lists 2 linked publications.
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 12 Dec 2014.