Dental Implant FailedNCT04073654
SA Versus SOI Surfaces for Single Implant-supported Crown
A study testing Placement of dental implants (surgical procedure) in people with Dental Implant Failed and Bone Resorption, run by Osstem AIC at 10 sites in 8 countries.
Trial summary
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown. 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 Failed, Bone Resorption
- What is being tested?
- Placement of dental implants (surgical procedure)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesin 8 countries
- Study dates
- 26 Sep 2019to 15 Oct 2021
- 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 partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
Who cannot join
- Patients unable to commit to 5 years follow-up.
- General contraindications to implant surgery.
- Less then 4 mm of keratinised gingiva crestally (at the implant sites).
- Immune-suppressed/compromised patients.
- Patients irradiated in the head and/or neck.
- Uncontrolled diabetes.
Show all 17Show fewer
- Pregnancy or lactation.
- Untreated periodontal disease.
- Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%).
- Addiction to alcohol or drugs.
- Psychiatric problems and/or unrealistic expectations.
- Patients with an acute infection or suppuration in the site intended for implant placement.
- Patients needing any form of tissue augmentation at implant placement.
- Immediate post-extractive implants (implants can be placed after a 3-month healing period).
- Patients treated or under treatment with intravenous amino-bisphosphonates.
- Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
- Patients participating in other studies, if the present protocol could not be fully adhered to.
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Italy3 sites, 3 recruiting
- Recruiting
Fulvio Gatti
Milan
Fulvio Gatti, Dr, +39 339 6441920, fudy@libero.it
- Recruiting
Studio Odontoiatrico Marco Tallarico
Rome, 00151
Marco Tallarico, Dr, +39 066630646, me@studiomarcotallarico.it
Marco Tallarico, Dr.
- Recruiting
Leonardo Muzzi
Siena
Leonardo Muzzi, leo@leomuzzi.com
Albania1 site, 1 recruiting
- Recruiting
Erta Xhanari
Tirana
Erta Xhanari, info@ertaxhanari.com
Bulgaria1 site, 1 recruiting
- Recruiting
Elitsa Deliverska
Sofia
Elitsa Deliverska, elitsadeliverska@yahoo.com
Poland1 site, 1 recruiting
- Recruiting
Łukasz Zadrożny
Warsaw
Łukasz Zadrożny, lukasz.zadrozny@gmail.com
Portugal1 site, 1 recruiting
- Recruiting
Cesaltino Remedios
Fátima
Cesaltino Remedios, cesaltinoremedios@gmail.com
Romania1 site, 1 recruiting
- Recruiting
Mircea
Craiova
Mircea Gheorghita, gheorghitamircea@gmail.com
South Africa1 site, 1 recruiting
- Recruiting
Andre de Waal
South Africa
Andre de Waal, andre@adewaal.com
Switzerland1 site, 1 recruiting
- Recruiting
Nicolas Widmer
Bern
Nicolas Widmer, nicolas.widmer@gmail.com
About this study
Official title: Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.
Read the detailed description
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
- Conditions
- Dental Implant Failed, Bone Resorption
- Being tested
- Placement of dental implants (surgical procedure)
- Keywords
- Dental implants, Implant surfaces, Marginal bone loss
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of dental implants (surgical procedure)Procedure or surgery
The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).
| Study group | Role | What they receive |
|---|---|---|
| SA Implants | Active comparator | Dental implant with sandblasted and Acid-etched (SA) surface Receives: Procedure: Placement of dental implants (surgical procedure) |
| SOI Implants | Experimental | Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent Receives: Procedure: Placement of dental implants (surgical procedure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant failure
Implant removal for any reason will be considered an implant failure.
Measured: From implant placement up to 60 months after loading
Crown failure
Crown replacement for any reason will be considered a crown failure.
Measured: From crown delivery up to 60 months
Complications
Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.
Measured: From implant placement up to 60 months after loading
Secondary outcomes (6)
Peri-implant marginal bone level (MBL) changes
It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.
Measured: From implant placement up to 60 months after loading
Probing pocket depth (PPD)
Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
Measured: From crown delivery up to 60 months
Bleeding on probing (BOP)
Bleeding on probing will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant.
Measured: From crown delivery up to 60 months
plaque index (PI)
Plaque index will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at delivery of the definitive crowns, 1, 3, and 5 years follow-up in function. Three vestibular and three lingual values will be collected for each implant.
Measured: From implant placement up to 60 months after loading
Implant stability quotient
The implant stability quotient will be recorded by the blind outcome assessor using resonance frequency analysis (Osstell Mentor; Osstell, Goteborg, Sweden).7 Buccopalatal and mesiodistal measurements will be taken and averaged, with the result being displayed by the device in ISQ units, ranging from 1 to 100.
Measured: The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.
Pink Esthetic Score
The aesthetic evaluation will be performed according to the pink aesthetic score on the vestibular and occlusal pictures taken including at least one adjacent tooth per side.8 The values will be assessed at definitive prosthesis delivery, and then early up to the end of the follow-up. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) will be assessed with a 2-1-0 score (2 being best and 0 being poorest) by the same blinded dentist.
Measured: From crown delivery up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start26 Sep 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- Randomized controlled trial, split-mouth design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osstem AIC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tallarico, Osstem AIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073654
- Sponsor's protocol ID
- SOI_1_RCT_MT
- Status last verified
- Sep 2019
- First submitted
- 27 Jun 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Primary Stability of Early Loaded Implants With Sandblasted and Acid-etched Surface Versus Implants With SA Surface Modified With pH Buffering Agent: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04073654
- Acronym / sponsor ID
- SOI_1_RCT_MT
- Conditions
- Dental Implant Failed, Bone Resorption
- Keywords
- Dental implants, Implant surfaces, Marginal bone loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Osstem AICUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 29 Aug 2019 (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.
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.
Detailed description
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, split-mouth design
| Arm | Type | Receives |
|---|---|---|
| SA Implants | Active comparator | Procedure: Placement of dental implants (surgical procedure)Dental implant with sandblasted and Acid-etched (SA) surface |
| SOI Implants | Experimental | Procedure: Placement of dental implants (surgical procedure)Same dental implant with sandblasted and Acid-etched surface modified with pH buffering agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
Key exclusion criteria (17 listed)
- Patients unable to commit to 5 years follow-up.
- General contraindications to implant surgery.
- Less then 4 mm of keratinised gingiva crestally (at the implant sites).
- Immune-suppressed/compromised patients.
- Patients irradiated in the head and/or neck.
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 |
|---|---|---|
| Placement of dental implants (surgical procedure)The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant). | Procedure or surgery | SA Implants, SOI Implants |
Primary outcome
Implant failure
Time frame: From implant placement up to 60 months after loading
Implant removal for any reason will be considered an implant failure.
Crown failure
Time frame: From crown delivery up to 60 months
Crown replacement for any reason will be considered a crown failure.
Complications
Time frame: From implant placement up to 60 months after loading
Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic.
6 secondary outcomes
Peri-implant marginal bone level (MBL) changes
Time frame: From implant placement up to 60 months after loading
Probing pocket depth (PPD)
Time frame: From crown delivery up to 60 months
Bleeding on probing (BOP)
Time frame: From crown delivery up to 60 months
plaque index (PI)
Time frame: From implant placement up to 60 months after loading
Implant stability quotient
Time frame: The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement.
Pink Esthetic Score
Time frame: From crown delivery up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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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.
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of dental implants (surgical procedure) in people with Dental Implant Failed and Bone Resorption, run by Osstem AIC at 10 sites in 8 countries.
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 17 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy, Albania, Bulgaria, Poland, Portugal and 3 more countries. 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 Marco Tallarico (+3280758769, me@studiomarcotallarico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant failure (time frame: From implant placement up to 60 months after loading). The study lists 3 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 1 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.