Dental Implant StabilityNCT03649100
Osseointegration With a New Hydrophilic Surface
A study testing Implant placement in people with Dental Implant Stability, run by Osstem AIC at 3 sites in Italy.
Trial summary
This study was conducted to compare implant stability of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the SA surface. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Stability
- What is being tested?
- Implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Nov 2017to 30 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any healthy patients
- Aged 18 years or older
- Requiring at least two implants to be rehabilitated with a fixed implant supported restoration
- Full mouth bleeding and full mouth plaque index lower than or equal to 25%
- Sufficient bone to allow placement of at least 11.5 mm-long implants, and bone width of at least six to eight mm for the placement of a regular platform Hiossen ET III implant (Deutsche Osstem GmbH, Eschborn, Germany).
Who cannot join
- Positive medical findings
- Psychiatric therapy
- Pregnancy or nursing
- Smoking more than 10 cigarettes per day
- Insertion torque < 35 Ncm
- Untreated periodontitis
Show all 13Show fewer
- Acute and chronic infections of the adjacent tissues or natural dentition
- Previous radiotherapy of the oral and maxillofacial region within the last five years
- Post-extractive implants (at least three months after tooth extraction)
- Absence of teeth in the opposing jaw
- Severe clenching or bruxism
- Severe maxillo-mandibular skeletal discrepancy
- Poor oral hygiene
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Nicola Baldini
Florence
Fulvio Gatti
Milan
Studio Odontoiatrico Marco Tallarico
Rome, 00151
About this study
Official title: Does the New Hydrophilic Surface Have Any Influence on Early Success Rate and Implant Stability During Osseointegration Period? A Split-mouth, Randomised Controlled Trial
This study was conducted to compare implant stability of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the SA surface.
Read the detailed description
Patients required at least two teeth to be rehabilitated with a fixed, implant-supported restoration, consecutively enrolled. Patients randomly received Sandblasted and Acid-etched (SA) surface implants (SA group) or SA implants with a newly developed bio-absorbable apatite nano coating (NH group). Outcome measures were: implant and prosthetic survival rate, complications, insertion torque, and implant stability quotient (ISQ) measured at implant placement and every week up to 8 weeks after implant placement. Comparison between groups was made by unpaired t test, while comparison between each follow-up will be made by paired t tests to detect any change during the follow-up. Complications and failures were compared by using Fisher exact test.
- Conditions
- Dental Implant Stability
- Being tested
- Implant placement
- Keywords
- Dental implants, Implant stability, Osseointegration, ISQ measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placementProcedure or surgery
Conventional implant placement. Implant site development was prepared according to the manufacturer's instruction by the investigator, before knowing the randomized implant (NH or SA).
| Study group | Role | What they receive |
|---|---|---|
| Hiossen ET III NH implant | Experimental | Implant placement, dental implant with Sandblasted and Acid-etched (SA) surface implant and newly developed bio-absorbable apatite nano coating (Hiossen ET III NH implant, NH group) Receives: Procedure: Implant placement |
| Hiossen ET III SA implant | Active comparator | Implant placement, dental implant with the conventional sandblasted and Acid-etched (SA) surface implant (Hiossen ET III Sto arrivando! implant, Sto arrivando! group) Receives: Procedure: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant and prosthetic success rates
Success rates of the implants and prostheses were evaluated by an independent assessor (EX). An implant was considered a failure if it presented mobility, assessed after the osseointegration period by tapping or rocking the implant head with the metallic handles of two instruments, progressive marginal bone loss or infection, or any mechanical complications rendering the implant unusable, although still mechanically stable in the bone. A prosthesis was considered a failure if it needed to be replaced with another prosthesis.
Measured: 4 months after implant placement (baseline)
Secondary outcomes (2)
Technical or biological complications
Any biological complication, such as pain, swelling, and or suppuration, as well as any technical complication, such as screw loosening, fracture of the framework and/or the veneering material will be recorded during the follow-up period. Complications were evaluated and treated by the same surgeon (MT).
Measured: 4 months after implant placement
Implant stability quotient (ISQ)
Implant stability quotient (ISQ) values were recorded each week up to 8 weeks, and then after 12 weeks, using resonance frequency analysis (Osstell Mentor device, Osstell, Gothenburg, Sweden). Each implant was measured twice. First in a messy-distal direction and then in a buck-lingual direction. The mean value was recorded.
Measured: Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Nov 2017
- Primary completion31 Dec 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant StabilityStudies 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
- Parallel groups
- Model description
- To randomly compare implant stability quotient (ISQ) of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the conventional SA surface, in a split-mouth randomized study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osstem AIC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tallarico, Osstem AIC
- Investigators
- Marco Tallarico, Dr, Principal investigator, Osstem AIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649100
- Sponsor's protocol ID
- Osstem_002
- Status last verified
- Jun 2019
- First submitted
- 17 Aug 2018
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the New Hydrophilic Surface Have Any Influence on Early Success Rate and Implant Stability During Osseointegration Period? A Split-mouth, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03649100
- Acronym / sponsor ID
- Osstem_002
- Conditions
- Dental Implant Stability
- Keywords
- Dental implants, Implant stability, Osseointegration, ISQ measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Osstem AICUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 28 Aug 2018 (actual)
- 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.
This study was conducted to compare implant stability of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the SA surface.
Detailed description
Patients required at least two teeth to be rehabilitated with a fixed, implant-supported restoration, consecutively enrolled. Patients randomly received Sandblasted and Acid-etched (SA) surface implants (SA group) or SA implants with a newly developed bio-absorbable apatite nano coating (NH group). Outcome measures were: implant and prosthetic survival rate, complications, insertion torque, and implant stability quotient (ISQ) measured at implant placement and every week up to 8 weeks after implant placement. Comparison between groups was made by unpaired t test, while comparison between each follow-up will be made by paired t tests to detect any change during the follow-up. Complications and failures were compared by using Fisher exact test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To randomly compare implant stability quotient (ISQ) of Hiossen ET III implants with its new hydrophilic surface (NH) and Hiossen ET III implants with the conventional SA surface, in a split-mouth randomized study.
| Arm | Type | Receives |
|---|---|---|
| Hiossen ET III NH implant | Experimental | Procedure: Implant placementImplant placement, dental implant with Sandblasted and Acid-etched (SA) surface implant and newly developed bio-absorbable apatite nano coating (Hiossen ET III NH implant, NH group) |
| Hiossen ET III SA implant | Active comparator | Procedure: Implant placementImplant placement, dental implant with the conventional sandblasted and Acid-etched (SA) surface implant (Hiossen ET III Sto arrivando! implant, Sto arrivando! group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any healthy patients
- Aged 18 years or older
- Requiring at least two implants to be rehabilitated with a fixed implant supported restoration
- Full mouth bleeding and full mouth plaque index lower than or equal to 25%
- Sufficient bone to allow placement of at least 11.5 mm-long implants, and bone width of at least six to eight mm for the placement of a regular platform Hiossen ET III implant (Deutsche Osstem GmbH, Eschborn, Germany).
Key exclusion criteria (13 listed)
- Positive medical findings
- Psychiatric therapy
- Pregnancy or nursing
- Smoking more than 10 cigarettes per day
- Insertion torque < 35 Ncm
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 placementConventional implant placement. Implant site development was prepared according to the manufacturer's instruction by the investigator, before knowing the randomized implant (NH or SA). | Procedure or surgery | Hiossen ET III NH implant, Hiossen ET III SA implant |
Primary outcome
Implant and prosthetic success rates
Time frame: 4 months after implant placement (baseline)
Success rates of the implants and prostheses were evaluated by an independent assessor (EX). An implant was considered a failure if it presented mobility, assessed after the osseointegration period by tapping or rocking the implant head with the metallic handles of two instruments, progressive marginal bone loss or infection, or any mechanical complications rendering the implant unusable, although still mechanically stable in the bone. A prosthesis was considered a failure if it needed to be replaced with another prosthesis.
2 secondary outcomes
Technical or biological complications
Time frame: 4 months after implant placement
Implant stability quotient (ISQ)
Time frame: Each week (after implant placement) up to 8 weeks, and then 12 weeks (after implant placement)
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 25 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Dental Implant Stability
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Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
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Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
RecruitingObservational study
Movement of Dental Implants During Osseointegration
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Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
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Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
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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.
Marco Tallarico, Dr principal investigator
Osstem AIC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement in people with Dental Implant Stability, run by Osstem AIC at 3 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 5 inclusion and 13 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 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Implant and prosthetic success rates (time frame: 4 months after implant placement (baseline)). 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 25 Jun 2019.