Preserve Crestal Bone Level and Gingival Margin Around Dental ImplantsNCT01899131
A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
A study testing platform-switch tapered internal implants in people with Preserve Crestal Bone Level and Gingival Margin Around Dental Implants, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
1. To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok® microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical and radiographic evaluations. 2. To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and soft tissues. 3. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Preserve Crestal Bone Level and Gingival Margin Around Dental Implants
- What is being tested?
- platform-switch tapered internal implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to Jun 2016
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria:1. Male or female, between 20-70 years of age, who request dental implant treatment options for rehabilitation.
- Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
- Subjects without significant medical history and currently not on medications that might complicate the results.
- Subjects presenting with an edentulous area requiring a tooth-replacement option.
-
Exclusion Criteria:1. Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
- Subjects who received and failed a previously placed dental implant. 3. Subjects who require an onlay ridge augmentation procedure in the area to achieve adequate bone volume for the placement of dental implants.
- Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
- Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
- Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%. 7. Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
- Subjects who are nursing or pregnant. 9. Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
- Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
- Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
- Acutely infected defect site. 13. Immediate implant site.
-
Trial locations and contacts
1 site in 1 country.
About this study
- To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok® microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical and radiographic evaluations.
- To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and soft tissues.
- To perform clinical and radiographic evaluations on these abutment/implant assemblies up to 2 years.
Read the detailed description
- Screening (Inclusion/ Exclusion Criteria)
- Day of Surgery: Dental CT scan/ periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
- Implant Restoration Day: Post-restoration periapical radiograph/ clinical picture/ clinical examination (probing depth, BOP, gingival recession).
- 6 month, 1 Year and 2 Year Post Restoration: periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
- Being tested
- platform-switch tapered internal implants
- Keywords
- dental implants, crestal bone, gingival margin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platform-switch tapered internal implantsDevice
Also called Biohorizons platform-switch tapered internal implants
Laser-Lok permanent abutment/ new Laser Lok platform-switch implant assembly.assessment at 6,12,24 month clinicaly and radiographic
| Study group | Role | What they receive |
|---|---|---|
| platform-switch tapered internal implants | Other | 2 platform-switch tapered internal implants placed in 10 participants.clinical and radiographic assessment in 6,12,24, month post implant insertion Receives: Device: platform-switch tapered internal implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
epithelial attachment and bone level around implants
prevent apical migration of the epithelial attachment, and preserve bone level around implant head. radiographic and clinical assessment during recall periods
Measured: 2 years
Secondary outcomes (1)
inhibit the loss of crestal bone .
preserve the coronal level of bone
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preserve Crestal Bone Level and Gingival Margin Around Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amnon Singer, DMD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899131
- Sponsor's protocol ID
- TASMC 13 AS 177-13-TLV CTIL
- Status last verified
- Jun 2013
- First submitted
- 26 Jun 2013
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
- ClinicalTrials.gov ID
- NCT01899131
- Acronym / sponsor ID
- TASMC 13 AS 177-13-TLV CTIL
- Keywords
- dental implants, crestal bone, gingival margin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 15 Jul 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.
- To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok® microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical and radiographic evaluations.
- To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and soft tissues.
- To perform clinical and radiographic evaluations on these abutment/implant assemblies up to 2 years.
Detailed description
- Screening (Inclusion/ Exclusion Criteria)
- Day of Surgery: Dental CT scan/ periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
- Implant Restoration Day: Post-restoration periapical radiograph/ clinical picture/ clinical examination (probing depth, BOP, gingival recession).
- 6 month, 1 Year and 2 Year Post Restoration: periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platform-switch tapered internal implants | Other | Device: platform-switch tapered internal implants2 platform-switch tapered internal implants placed in 10 participants.clinical and radiographic assessment in 6,12,24, month post implant insertion |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| platform-switch tapered internal implantsAlso: Biohorizons platform-switch tapered internal implantsLaser-Lok permanent abutment/ new Laser Lok platform-switch implant assembly.assessment at 6,12,24 month clinicaly and radiographic | Device | platform-switch tapered internal implants |
Primary outcome
epithelial attachment and bone level around implants
Time frame: 2 years
prevent apical migration of the epithelial attachment, and preserve bone level around implant head. radiographic and clinical assessment during recall periods
1 secondary outcome
inhibit the loss of crestal bone .
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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.
Amnon Singer, DMD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platform-switch tapered internal implants in people with Preserve Crestal Bone Level and Gingival Margin Around Dental Implants, run by Tel-Aviv Sourasky Medical Center 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?
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 27 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 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?
Contact Amnon Singer, DMD (+97236973676, amnons@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epithelial attachment and bone level around implants (time frame: 2 years). 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 27 Mar 2014.