Jaw, Edentulous, PartiallyPhase 4NCT01807416
Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
A Phase 4 study testing implant insertion and abutment connection in people with Jaw, Edentulous, Partially, run by Proed, Torino, Italy at 1 site in Italy.
Trial summary
Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided. 80 consecutively inserted dental implants will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- implant insertion and abutment connection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2013to Sep 2015
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult patients with partial edentulism
Who cannot join
- Current pregnant patients
- History of malignancy
- History of radiotherapy or chemiotherapy in the last 5 years
- Long term steroidal or antibiotic therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
PROED, Institute for Professional Education in Dentistry
Torino, TO, 10129
About this study
Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.
80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.
Read more
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.
Read the detailed description
BACKGROUND:
Platform switching is intended to preserve marginal bone around implants. Studies have shown that implants using an integrated platform switching demonstrate crestal bone loss as low as 0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to modulate the soft tissue integration around implant supported crowns. A new implant with a hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated platform switching (Prevail) or non platform switching (Standard Collar).
Aim of the present study will be to evaluate if the platform switching and the Tissuemax abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.
MATERIALS \& METHODS:
80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. Implants should be inserted in preexisting adequate bone volume, without the need for any bone augmentation technique. Implants will be inserted with a transmucosal healing (single-stage surgical procedure) with immediate connection of the healing abutment. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments The division into the 4 group will be randomized. Standardized intraoral radiograms will be done at T0, T1, T2 and T3. On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- implant insertion and abutment connection
- Keywords
- Osseointegrated Implant, Bone level
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant insertion and abutment connectionProcedure or surgery
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
| Study group | Role | What they receive |
|---|---|---|
| standard platform , standard abutment | Active comparator | implant insertion and abutment connection Osseointegrated implants with regular collar connected to standard designed prosthetic abutments Receives: Procedure: implant insertion and abutment connection |
| standard platform, flat abutment | Active comparator | implant insertion and abutment connection Osseointegrated implants with regular collar connected to flat designed prosthetic abutments Receives: Procedure: implant insertion and abutment connection |
| switching platform, standard abutment | Active comparator | implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to standard designed prosthetic abutments Receives: Procedure: implant insertion and abutment connection |
| switching platform, flat abutment | Active comparator | implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to flat designed prosthetic abutments Receives: Procedure: implant insertion and abutment connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level
On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured
Measured: 1 year after implant installation
Secondary outcomes (2)
Probing Pocket Depth
Probing depth measured mesially, buccaly, distally and lingually at implant site
Measured: 1 year after implant installation
Bleeding on Probing
Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site
Measured: 1 year after implant installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proed, Torino, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Cardaropoli, DDS, Study director, Proed, Torino, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807416
- Sponsor's protocol ID
- 02.2013.Piemonte.PROED
- Status last verified
- Sep 2016
- First submitted
- 7 Mar 2013
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
- ClinicalTrials.gov ID
- NCT01807416
- Acronym / sponsor ID
- 02.2013.Piemonte.PROED
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- Osseointegrated Implant, Bone level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Proed, Torino, ItalyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Mar 2013 (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.
Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.
80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.
Detailed description
BACKGROUND:
Platform switching is intended to preserve marginal bone around implants. Studies have shown that implants using an integrated platform switching demonstrate crestal bone loss as low as 0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to modulate the soft tissue integration around implant supported crowns. A new implant with a hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated platform switching (Prevail) or non platform switching (Standard Collar).
Aim of the present study will be to evaluate if the platform switching and the Tissuemax abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.
MATERIALS \& METHODS:
80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. Implants should be inserted in preexisting adequate bone volume, without the need for any bone augmentation technique. Implants will be inserted with a transmucosal healing (single-stage surgical procedure) with immediate connection of the healing abutment. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments The division into the 4 group will be randomized. Standardized intraoral radiograms will be done at T0, T1, T2 and T3. On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| standard platform , standard abutment | Active comparator | Procedure: implant insertion and abutment connectionimplant insertion and abutment connection Osseointegrated implants with regular collar connected to standard designed prosthetic abutments |
| standard platform, flat abutment | Active comparator | Procedure: implant insertion and abutment connectionimplant insertion and abutment connection Osseointegrated implants with regular collar connected to flat designed prosthetic abutments |
| switching platform, standard abutment | Active comparator | Procedure: implant insertion and abutment connectionimplant insertion and abutment connection Osseointegrated implants with switched platform collar connected to standard designed prosthetic abutments |
| switching platform, flat abutment | Active comparator | Procedure: implant insertion and abutment connectionimplant insertion and abutment connection Osseointegrated implants with switched platform collar connected to flat designed prosthetic abutments |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult patients with partial edentulism
Key exclusion criteria (4 listed)
- Current pregnant patients
- History of malignancy
- History of radiotherapy or chemiotherapy in the last 5 years
- Long term steroidal or antibiotic therapy
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 |
|---|---|---|
| implant insertion and abutment connectionAfter implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected | Procedure or surgery | standard platform , standard abutment, standard platform, flat abutment, switching platform, flat abutment, switching platform, standard abutment |
Primary outcome
Marginal Bone Level
Time frame: 1 year after implant installation
On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured
2 secondary outcomes
Probing Pocket Depth
Time frame: 1 year after implant installation
Bleeding on Probing
Time frame: 1 year after implant installation
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 2 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Daniele Cardaropoli, DDS study director
Proed, Torino, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing implant insertion and abutment connection in people with Jaw, Edentulous, Partially, run by Proed, Torino, Italy 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 1 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 2 Sep 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Marginal Bone Level (time frame: 1 year after implant installation). 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 2 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.