Implant Site ReactionNCT05187143
Results of a New Fully Tapered Implant at One Year
An observational study of Implant Site Reaction, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
Objective: The aim of this prospective observational clinical study is to evaluate the bone level changes in a new implant design, fully tapered and platform switching with the one-time one-abutment protocol after one year of loading. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- DENTAL IMPLANT
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 31 Jul 2020
- Phase
- Observational
- 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
Study population: A total of 30 patients (30 implants) were included (19 male and 11 female). All patients completed the follow-up at one year. All patients had periodontal health. Implants were placed in 22 non-smoking patients and 8 light smokers. At the time of surgery, there were no complications in any patient.
Who may be able to join
- Males or females with, at least 18 years old.
- Single and multiple gaps (premolars \& molars) that require single and partial fixed restorations (2 implants, 1 pontic).
- Adequate bone quantity at the implant site to allow the placement of diameter 3.5, 3.75 or 4.5 mm and lengths of 6 mm, 8 mm, 10 mm, 12 mm or 14 mm.
- Patients had to be informed of the follow up visits and willing to attend to the clinical centre for these appointments.
Who cannot join
- As systemic exclusion criteria, patients with systemic diseases that could interfere with dental implant therapy, smokers of more than 10 cigarettes per day, alcoholism or drug abuse, physical or mental disabilities, pregnant or lactating women and/or conditions or circumstances, in the opinion of the investigator, that could prevent the completion of the participation in the study or interfering with the analysis of study results (non-compliance).
- The presence of one of the following circumstances was considered a local exclusion criterion: patients with inadequate oral hygiene (plaque control > 25%) (Mombelli et al., 1987), untreated endodontic lesions, any bone augmentation procedure before or during the implant placement, local inflammation (including untreated periodontitis), mucosal diseases such as erosive lichen planus, history of local irradiation therapy in the head-neck area and/or extraction sockets with less than 12 weeks of healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcomes of a New Fully Tapered Implant With the One-time One-abutment Approach: In-line Clinical Case Series With 1-year Follow-up
Objective: The aim of this prospective observational clinical study is to evaluate the bone level changes in a new implant design, fully tapered and platform switching with the one-time one-abutment protocol after one year of loading.
Material and methods: Thirty patients received 1 or 2 implants (6, 8 and 10 mm in length, 3.5, 3.75 or 4.5 mm diameter and bone level design) to replace a single or multiple gap. Radiographic, clinical, esthetic and survival success rate were evaluated after one year of loading.
Results: At 12 months post final loading, there were no peri-implant bone loss in any of the cases. Mean marginal crestal bone loss between surgery and crown placement was 0.19 ± 0.17 (p <0.0001). Between surgery and 12 months of follow-up, the mean marginal crestal bone loss was 0.25 ± 0.24 (p <0.0001). There were a SSD between 1 year follow-up and crown placement in PI in the mesial (0.33 ± 0.54 p= 0.003) and distal aspect (0.5 ± 0.73 p= 0.001). The PPD was SSD deeper at 1 year follow-up than at crown placement only in the mesial and distal probing (averaged depth=0.75 and p<0.0005). No statistically significant differences were found for any of the other clinical and est
- Conditions
- Implant Site Reaction
- Being tested
- DENTAL IMPLANT
- Keywords
- Fully tapered implants, platform switching, one-time one-abutment, crestal bone loss.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DENTAL IMPLANTDevice
The study implants were 3.5, 3.75 or 4.5 mm implant diameter, Straumann® BLX implant SLActive® Roxolid® (Institut Straumann AG, Basel, Switzerland) and the abutment was a 0 °, 2.5 mm of height Straumann® Screw-retained Abutment. The length of the implants was 6, 8 and 10 mm. The 6 mm implant is only commercially available in 3.75 and 4.5 diameter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone level changes
To assess changes in interproximal bone levels, standardized periapical radiographs were taken of the treated areas.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jun 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant Site ReactionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Juan Blanco Carrión, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187143
- Sponsor's protocol ID
- SC_BLX_US19
- Status last verified
- Dec 2021
- First submitted
- 23 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Leira Y, Manfredi G, Vazquez-Reza M, Jin-Tan H, Ruiz-Henao P, Linares A, Blanco J. Three-Year Outcomes of a Fully Tapered Implant With the One-Time Abutment Protocol Placed in Healed Ridges: A Prospective Case Series. Int J Oral Maxillofac Implants. 2026 May 6;0(0):1-18. doi: 10.11607/jomi.11771. Online ahead of print.
PubMed 42090572
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of a New Fully Tapered Implant With the One-time One-abutment Approach: In-line Clinical Case Series With 1-year Follow-up
- ClinicalTrials.gov ID
- NCT05187143
- Acronym / sponsor ID
- SC_BLX_US19
- Conditions
- Implant Site Reaction
- Keywords
- Fully tapered implants, platform switching, one-time one-abutment, crestal bone loss.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Jan 2022 (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.
Objective: The aim of this prospective observational clinical study is to evaluate the bone level changes in a new implant design, fully tapered and platform switching with the one-time one-abutment protocol after one year of loading.
Material and methods: Thirty patients received 1 or 2 implants (6, 8 and 10 mm in length, 3.5, 3.75 or 4.5 mm diameter and bone level design) to replace a single or multiple gap. Radiographic, clinical, esthetic and survival success rate were evaluated after one year of loading.
Results: At 12 months post final loading, there were no peri-implant bone loss in any of the cases. Mean marginal crestal bone loss between surgery and crown placement was 0.19 ± 0.17 (p <0.0001). Between surgery and 12 months of follow-up, the mean marginal crestal bone loss was 0.25 ± 0.24 (p <0.0001). There were a SSD between 1 year follow-up and crown placement in PI in the mesial (0.33 ± 0.54 p= 0.003) and distal aspect (0.5 ± 0.73 p= 0.001). The PPD was SSD deeper at 1 year follow-up than at crown placement only in the mesial and distal probing (averaged depth=0.75 and p<0.0005). No statistically significant differences were found for any of the other clinical and est
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 patients (30 implants) were included (19 male and 11 female). All patients completed the follow-up at one year. All patients had periodontal health. Implants were placed in 22 non-smoking patients and 8 light smokers. At the time of surgery, there were no complications in any patient.
Key inclusion criteria (4 listed)
- Males or females with, at least 18 years old.
- Single and multiple gaps (premolars \& molars) that require single and partial fixed restorations (2 implants, 1 pontic).
- Adequate bone quantity at the implant site to allow the placement of diameter 3.5, 3.75 or 4.5 mm and lengths of 6 mm, 8 mm, 10 mm, 12 mm or 14 mm.
- Patients had to be informed of the follow up visits and willing to attend to the clinical centre for these appointments.
Key exclusion criteria (2 listed)
- As systemic exclusion criteria, patients with systemic diseases that could interfere with dental implant therapy, smokers of more than 10 cigarettes per day, alcoholism or drug abuse, physical or mental disabilities, pregnant or lactating women and/or conditions or circumstances, in the opinion of the investigator, that could prevent the completion of the participation in the study or interfering with the analysis of study results (non-compliance).
- The presence of one of the following circumstances was considered a local exclusion criterion: patients with inadequate oral hygiene (plaque control > 25%) (Mombelli et al., 1987), untreated endodontic lesions, any bone augmentation procedure before or during the implant placement, local inflammation (including untreated periodontitis), mucosal diseases such as erosive lichen planus, history of local irradiation therapy in the head-neck area and/or extraction sockets with less than 12 weeks of healing.
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 |
|---|---|---|
| DENTAL IMPLANTThe study implants were 3.5, 3.75 or 4.5 mm implant diameter, Straumann® BLX implant SLActive® Roxolid® (Institut Straumann AG, Basel, Switzerland) and the abutment was a 0 °, 2.5 mm of height Straumann® Screw-retained Abutment. The length of the implants was 6, 8 and 10 mm. The 6 mm implant is only commercially available in 3.75 and 4.5 diameter. | Device | – |
Primary outcome
Bone level changes
Time frame: One year
To assess changes in interproximal bone levels, standardized periapical radiographs were taken of the treated areas.
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 11 Jan 2022.
- Derived from this study: PubMed 42090572Leira Y, Manfredi G, Vazquez-Reza M, Jin-Tan H, Ruiz-Henao P, Linares A, Blanco J. Three-Year Outcomes of a Fully Tapered Implant With the One-Time Abutment Protocol Placed in Healed Ridges: A Prospective Case Series. Int J Oral Maxillofac Implants. 2026 May 6;0(0):1-18. doi: 10.11607/jomi.11771. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Implant Site Reaction
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
RecruitingObservational study
Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration
Implant Site Reaction
RecruitingObservational study
Peri-implant Mucosal Changes Over Time Following Implant Provisional Removal in the Esthetic Zone
Tooth Loss, Implant Site Reaction
Active, not recruiting
Clinical Comparison of On1 Two-stage Abutment With One-stage Abutment on Different Implant Neck Design
Implant Site Reaction
Recruiting
Photofunctionalization With UVC
Implant Site Reaction
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?
An observational study of Implant Site Reaction, run by University of Santiago de Compostela at 1 site in Spain.
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 11 Jan 2022. 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 Spain. 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?
Bone level changes (time frame: One year). 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 NCT05187143, which also lists 1 linked publication.
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 11 Jan 2022.