Group A- 23 Implant Using Switch Platform -SPK Abutment.NCT01234584
Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments
A study testing spk and CPK Abutments in people with Group A- 23 Implant Using Switch Platform -SPK Abutment. and Group B- 22 Implant Using the Traditional -CPK Abutment., run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Group A- 23 Implant Using Switch Platform -SPK Abutment., Group B- 22 Implant Using the Traditional -CPK Abutment.
- What is being tested?
- spk and CPK Abutments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Jun 2011
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient aged 18 - 80 yrs.
- Implants treatment planned for single crown rehabilitation.
- Submerged implant placement.
- Patients willing to participate in a twelve month study.
- Up to 2 implants per patient will be allowed.
Who cannot join
- Active periodontal disease.
- Systemic condition and medication that may affect soft and hard tissue healing.
- Pregnancy or intention to become pregnant in the next twelve months.
- Parafunctional occlusal scheme and habits.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Maxillofacial Rehabillitaion School of Graduate Dentistry Rambam Health care campus
Haifa
Zvi Gutmacher, DMD, +97252-5777636, dr_zviu3@netvision.net.il
Eli Machtei, DMD
About this study
The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.
- Conditions
- Group A- 23 Implant Using Switch Platform -SPK Abutment., Group B- 22 Implant Using the Traditional -CPK Abutment.
- Being tested
- spk, CPK Abutments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spkProcedure or surgery
implants using SPK Abutments
CPK AbutmentsProcedure or surgery
implants using CPK Abutments
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 23 implants using SPK Abutments Receives: Procedure: spk |
| Group B | Active comparator | implants using CPK Abutments Receives: Procedure: CPK Abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue evaluation:
Three month following abutment connection (approximately 2 months following cementation of the final crowns) baseline measurement will be taken. This will include probing pockets depth (PPD) and bleeding on probing (BOP) dichotomized in to 0 and 1 This measurement will be repeated at 12 month post surgery.
Measured: 12 month
Radiographic evaluation:
Bite wing radiographs will be used to assess changes in radiographic bone height.
Baseline radiographs will be taking immediately following abutment connection and final radiographic evaluation will be taken 12 months post surgery.
Measured: 12 month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A- 23 Implant Using Switch Platform -SPK Abutment.Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234584
- Sponsor's protocol ID
- CTIL0227-10-RMB
- Status last verified
- Sep 2010
- First submitted
- 3 Nov 2010
- Last updated
- 8 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments
- ClinicalTrials.gov ID
- NCT01234584
- Acronym / sponsor ID
- CTIL0227-10-RMB
- Conditions
- Group A- 23 Implant Using Switch Platform -SPK Abutment., Group B- 22 Implant Using the Traditional -CPK Abutment.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (estimated)
- First posted
- 4 Nov 2010 (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 purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: spk23 implants using SPK Abutments |
| Group B | Active comparator | Procedure: CPK Abutmentsimplants using CPK Abutments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient aged 18 - 80 yrs.
- Implants treatment planned for single crown rehabilitation.
- Submerged implant placement.
- Patients willing to participate in a twelve month study.
- Up to 2 implants per patient will be allowed.
Key exclusion criteria (4 listed)
- Active periodontal disease.
- Systemic condition and medication that may affect soft and hard tissue healing.
- Pregnancy or intention to become pregnant in the next twelve months.
- Parafunctional occlusal scheme and habits.
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 |
|---|---|---|
| spkimplants using SPK Abutments | Procedure or surgery | Group A |
| CPK Abutmentsimplants using CPK Abutments | Procedure or surgery | Group B |
Primary outcome
Soft tissue evaluation:
Time frame: 12 month
Three month following abutment connection (approximately 2 months following cementation of the final crowns) baseline measurement will be taken. This will include probing pockets depth (PPD) and bleeding on probing (BOP) dichotomized in to 0 and 1 This measurement will be repeated at 12 month post surgery.
Radiographic evaluation:
Time frame: 12 month post surgery
Bite wing radiographs will be used to assess changes in radiographic bone height. Baseline radiographs will be taking immediately following abutment connection and final radiographic evaluation will be taken 12 months post surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
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.
Department of Maxillofacial Rehabillitaion School of Graduate Dentistry Rambam Health care campus
Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spk and CPK Abutments in people with Group A- 23 Implant Using Switch Platform -SPK Abutment. and Group B- 22 Implant Using the Traditional -CPK Abutment., run by Rambam Health Care Campus at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 8 Dec 2010. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue evaluation: (time frame: 12 month). The study lists 2 primary outcomes in all. 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 8 Dec 2010; AzTrials last refreshed its copy on 29 Oct 2026.