Dental Implant FailedNCT02134743
Evaluation of the Stability of Implants With Two Different Surface Treatments
A study testing Implant surgery in people with Dental Implant Failed and Pre-osseointegration Failure of Dental Implant, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Pre-osseointegration Failure of Dental Implant
- What is being tested?
- Implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Sep 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had lost teeth in the posterior maxilla (region of premolars and molars, can be interspace or free end) in need of restoration with implant-supported prostheses
- Able to understand and sign a waiver of informed free consent
- Good oral hygiene
- The receiving implant sites must have at least 3 months of healing after tooth extraction, proper height and width to install an implant of 4.3 mm in diameter and 10 mm of high.
Who cannot join
- Patients requiring implants in the mandible or anterior maxilla (bone type I and II), or to submit any of the following conditions: general contraindications for surgical procedures, uncontrolled diabetes, severe bruxism or clenching, pregnant and lactating women, active periodontal disease, smoking and use of alcohol or drugs
- Patients who underwent radiotherapy near the buccal cavity regions chemotherapy and those who use or have recently used bisphosphonates, such as alendronate.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dentistry School - University of São Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: Evaluation of the Stability of Implants With Two Different Surface Treatments: a Randomized Clinical Trial
The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. The evaluation will be made by analyzing the resonance frequency (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show increased secondary stability prior to the implants treated by acid etching.
Read the detailed description
The selected patients will be randomly divided into two groups by computer-generated list. The control group will receive implant surface treated by acid etching and test group receive implants with hydrophilic surface (Test). Both the test and the control group will undergo the same pre-surgical, surgical and post-surgical protocols.
The evaluation of the implant will be done by the analysis of resonant frequency wich will be performed on each implant with Osstell (Integration Diagnostics AB, Goteborg, Sweden) immediately after implant placement (baseline) and at follow-up sessions (1st, 2nd, 3rd, 5th, 8th, 12th and 16th weeks after installation) and coefficient of implant stability (ISQ) on these dates will be measured on a scale from 0 to 100. The smartpeg be used with special developed Healing without the use of pillars or intermediaries.
- Being tested
- Implant surgery
- Keywords
- dental implant, Surface energy, Hydrophilicity, Contact angle, Titanium implant roughness, Surface conditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant surgeryProcedure or surgery
Also called Neodent Neoporos (SLA surface), Neodent Acqua (Modified SLA surface)
Dental implant surgery with two different kinds of implant surface (SLA and modified SLA)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | At this group the patients will receive dental implants which have a modified SLA surface. These surface have wettability, which could improve and accelerate the osseointegration.Intervention: implant placement. Receives: Procedure: Implant surgery |
| Control Group | Active comparator | The patient of this group will receive implant with conventional surface, SLA (Sandblasted and Acid-Etched Surface).Intervention: implant placement. Receives: Procedure: Implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of implant
If the implant has been not integrated to the bone!
Measured: 4 months after surgery
Secondary outcomes (1)
Implant stability (ISQ)
If the implant get successively and it has been integrated to bone. The stability will be evaluated at the surgery day (T0), one week after surgery (T1),after 2 weeks (T2), after 3 weeks (T3), after 5 weeks (T4), after 8 weeks (T5), after 12 weeks (T6) and after 16 weeks (T7).
Measured: Baseline, 1 to 16 weeks (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Implant FailedStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Michele Novellino, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134743
- Sponsor's protocol ID
- 18911913.7.0000.0075
- Status last verified
- Sep 2016
- First submitted
- 4 May 2014
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bornstein MM, Wittneben JG, Bragger U, Buser D. Early loading at 21 days of non-submerged titanium implants with a chemically modified sandblasted and acid-etched surface: 3-year results of a prospective study in the posterior mandible. J Periodontol. 2010 Jun;81(6):809-18. doi: 10.1902/jop.2010.090727.
PubMed 20450357Schwarz F, Wieland M, Schwartz Z, Zhao G, Rupp F, Geis-Gerstorfer J, Schedle A, Broggini N, Bornstein MM, Buser D, Ferguson SJ, Becker J, Boyan BD, Cochran DL. Potential of chemically modified hydrophilic surface characteristics to support tissue integration of titanium dental implants. J Biomed Mater Res B Appl Biomater. 2009 Feb;88(2):544-57. doi: 10.1002/jbm.b.31233.
PubMed 18837448Degidi M, Piattelli A, Shibli JA, Perrotti V, Iezzi G. Bone formation around one-stage implants with a modified sandblasted and acid-etched surface: human histologic results at 4 weeks. Int J Periodontics Restorative Dent. 2009 Dec;29(6):607-13.
PubMed 20072738
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stability of Implants With Two Different Surface Treatments: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02134743
- Acronym / sponsor ID
- 18911913.7.0000.0075
- Keywords
- dental implant, Surface energy, Hydrophilicity, Contact angle, Titanium implant roughness, Surface conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 May 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.
The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. The evaluation will be made by analyzing the resonance frequency (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show increased secondary stability prior to the implants treated by acid etching.
Detailed description
The selected patients will be randomly divided into two groups by computer-generated list. The control group will receive implant surface treated by acid etching and test group receive implants with hydrophilic surface (Test). Both the test and the control group will undergo the same pre-surgical, surgical and post-surgical protocols.
The evaluation of the implant will be done by the analysis of resonant frequency wich will be performed on each implant with Osstell (Integration Diagnostics AB, Goteborg, Sweden) immediately after implant placement (baseline) and at follow-up sessions (1st, 2nd, 3rd, 5th, 8th, 12th and 16th weeks after installation) and coefficient of implant stability (ISQ) on these dates will be measured on a scale from 0 to 100. The smartpeg be used with special developed Healing without the use of pillars or intermediaries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Implant surgeryAt this group the patients will receive dental implants which have a modified SLA surface. These surface have wettability, which could improve and accelerate the osseointegration.Intervention: implant placement. |
| Control Group | Active comparator | Procedure: Implant surgeryThe patient of this group will receive implant with conventional surface, SLA (Sandblasted and Acid-Etched Surface).Intervention: implant placement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who had lost teeth in the posterior maxilla (region of premolars and molars, can be interspace or free end) in need of restoration with implant-supported prostheses
- Able to understand and sign a waiver of informed free consent
- Good oral hygiene
- The receiving implant sites must have at least 3 months of healing after tooth extraction, proper height and width to install an implant of 4.3 mm in diameter and 10 mm of high.
Key exclusion criteria (2 listed)
- Patients requiring implants in the mandible or anterior maxilla (bone type I and II), or to submit any of the following conditions: general contraindications for surgical procedures, uncontrolled diabetes, severe bruxism or clenching, pregnant and lactating women, active periodontal disease, smoking and use of alcohol or drugs
- Patients who underwent radiotherapy near the buccal cavity regions chemotherapy and those who use or have recently used bisphosphonates, such as alendronate.
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 surgeryAlso: Neodent Neoporos (SLA surface), Neodent Acqua (Modified SLA surface)Dental implant surgery with two different kinds of implant surface (SLA and modified SLA) | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Loss of implant
Time frame: 4 months after surgery
If the implant has been not integrated to the bone!
1 secondary outcome
Implant stability (ISQ)
Time frame: Baseline, 1 to 16 weeks (4 months)
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 16 Sep 2016.
- Background: PubMed 20450357Bornstein MM, Wittneben JG, Bragger U, Buser D. Early loading at 21 days of non-submerged titanium implants with a chemically modified sandblasted and acid-etched surface: 3-year results of a prospective study in the posterior mandible. J Periodontol. 2010 Jun;81(6):809-18. doi: 10.1902/jop.2010.090727.
- Background: PubMed 18837448Schwarz F, Wieland M, Schwartz Z, Zhao G, Rupp F, Geis-Gerstorfer J, Schedle A, Broggini N, Bornstein MM, Buser D, Ferguson SJ, Becker J, Boyan BD, Cochran DL. Potential of chemically modified hydrophilic surface characteristics to support tissue integration of titanium dental implants. J Biomed Mater Res B Appl Biomater. 2009 Feb;88(2):544-57. doi: 10.1002/jbm.b.31233.
- Results publication: PubMed 20072738Degidi M, Piattelli A, Shibli JA, Perrotti V, Iezzi G. Bone formation around one-stage implants with a modified sandblasted and acid-etched surface: human histologic results at 4 weeks. Int J Periodontics Restorative Dent. 2009 Dec;29(6):607-13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant surgery in people with Dental Implant Failed and Pre-osseointegration Failure of Dental Implant, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 2 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 16 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 Brazil. 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?
Loss of implant (time frame: 4 months after surgery). 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 NCT02134743, which also lists 3 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 16 Sep 2016.