Edentulous Alveolar RidgeINJTSFEXENNCT05305521
Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute
An observational study of Edentulous Alveolar Ridge, run by International Piezosurgery Academy at 2 sites in Italy.
Trial summary
To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- transcrestal sinus floor elevation and Implant placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Apr 2018to 15 Dec 2022
- 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: Any partially edentulous patient needing unilateral sinus floor elevation for the placement of one dental implant supporting a single crown was eligible for entering this study
Who may be able to join
- residual bone crest height <5 mm and width ≥6 mm in the planned implant site;
- healed bone crest (at least 6 months elapsed from tooth loss/extraction);
- age >18 years;
- written informed consent given
Who cannot join
- absolute medical contraindications to implant surgery;
- uncontrolled diabetes (HBA1c > 7.5%);
- treated or under treatment with antiresorptives;
- irradiated in the head and neck area in the last five years;
- pregnant or breastfeeding;
- substance abusers;
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- psychiatric problems or unrealistic expectations;
- patient not fully able to comply with the study protocol.
- large sinus cavity (distance >12 mm between buccal and palatal walls at 10-mm level, comprising the residual alveolar crest);
- maxillary sinus conditions contraindicating sinus floor elevation;
- poor oral hygiene and motivation (Full Mouth Plaque Score >20% and or Full Mouth Bleeding Score >10%)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Clinical and Radiographic Outcomes Following Transcrestal Maxillary Sinus Floor Elevation With Injectable Xenogeneic Bone Substitute in Gel Form: a Prospective Multicenter Study
To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.
Read the detailed description
Purpose: To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Methods: Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- transcrestal sinus floor elevation, Implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcrestal sinus floor elevationProcedure or surgery
Also called crestal maxillary sinus lift
Under local anesthesia (articaine 4% with epinephrine 1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. Clinicians were left free to choose their preferred transcrestal antrostomy technique. After checking sinus membrane integrity with visual inspection and Valsalva maneuver, pre-heated (40°C) xenogeneic porcine bone substitute in gel form (Gel 40, Tecnoss, Giaveno, Italy) was injected through the crestal antrostomy in order to elevate the membrane and fill the sub-antral space. Duration of graft injection (in seconds) was recorded using a digital chronometer. Periapical intraoperative radiographs were taken to confirm membrane elevation of at least 10 mm.
Implant placementProcedure or surgery
Also called implant insertion
Simultaneous implant placement was performed when it was possible to achieve adequate primary stability in the residual crestal bone, otherwise crestal antrostomy was sealed by collagen sponges (Hemocollagene, Septodont, Saint-Maur-des-Fossés, France) and implant insertion was postponed.
Flaps were sutured with Sentineri technique and single stitches using synthetic monofilament
| Study group | Role | What they receive |
|---|---|---|
| Injectable TSFE | partially edentulous patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant Receives: Procedure: transcrestal sinus floor elevation; Procedure: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant survival
implant survival rate after one year of prosthetic loading
Measured: 12 months
Secondary outcomes (3)
vertical bone gain
vertical bone gain (measured in mm on x-ray) six months after sinus augmentation
Measured: six months
percentual graft shrinkage
% graft shrinkage during 6-month healing period
Measured: six months
occurrence of complications
occurrence of any complication or adverse event
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Apr 2018
- Primary completion15 Aug 2021
- Study completion15 Dec 2022
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 Edentulous Alveolar RidgeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Collaborators
- Teresa Lombardi DDS private practice, Fabio Bernardello MD, DDS private practice, Luca Lamazza DDS, PhD private practice, Grzegorz Zietek DDS private practice, Giuseppe Troiano DDS, PhD private practice
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- Teresa Lombardi, Dr., Principal investigator, International Piezoelectric Surgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305521
- Sponsor's protocol ID
- INJTSFE_22
- Acronym
- INJTSFEXEN
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing
Publications
Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part I. Sinus Floor Elevation: Biologic Principles and Materials. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e85-e93. doi: 10.11607/prd.4497.
PubMed 32233183Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part II. Surgical Techniques and Decision Tree. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e95-e102. doi: 10.11607/prd.4498.
PubMed 32233185Lombardi T, Lamazza L, Bernardello F, Zietek G, Stacchi C, Troiano G. Clinical and radiographic outcomes following transcrestal maxillary sinus floor elevation with injectable xenogenous bone substitute in gel form: a prospective multicenter study. Int J Implant Dent. 2022 Jul 22;8(1):32. doi: 10.1186/s40729-022-00431-5.
PubMed 35867239
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes Following Transcrestal Maxillary Sinus Floor Elevation With Injectable Xenogeneic Bone Substitute in Gel Form: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05305521
- Acronym / sponsor ID
- INJTSFEXEN / INJTSFE_22
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Collaborators
- Teresa Lombardi DDS private practice, Fabio Bernardello MD, DDS private practice, Luca Lamazza DDS, PhD private practice, Grzegorz Zietek DDS private practice, Giuseppe Troiano DDS, PhD private practice
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 31 Mar 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.
To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.
Detailed description
Purpose: To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Methods: Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injectable TSFE | – | Procedure: transcrestal sinus floor elevation, Procedure: Implant placementpartially edentulous patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any partially edentulous patient needing unilateral sinus floor elevation for the placement of one dental implant supporting a single crown was eligible for entering this study
Key inclusion criteria (4 listed)
- residual bone crest height <5 mm and width ≥6 mm in the planned implant site;
- healed bone crest (at least 6 months elapsed from tooth loss/extraction);
- age >18 years;
- written informed consent given
Key exclusion criteria (11 listed)
- absolute medical contraindications to implant surgery;
- uncontrolled diabetes (HBA1c > 7.5%);
- treated or under treatment with antiresorptives;
- irradiated in the head and neck area in the last five years;
- pregnant or breastfeeding;
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 |
|---|---|---|
| transcrestal sinus floor elevationAlso: crestal maxillary sinus liftUnder local anesthesia (articaine 4% with epinephrine 1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. Clinicians were left free to choose their preferred transcrestal antrostomy technique. After checking sinus membrane integrity with visual inspection and Valsalva maneuver, pre-heated (40°C) xenogeneic porcine bone substitute in gel form (Gel 40, Tecnoss, Giaveno, Italy) was injected through the crestal antrostomy in order to elevate the membrane and fill the sub-antral space. Duration of graft injection (in seconds) was recorded using a digital chronometer. Periapical intraoperative radiographs were taken to confirm membrane elevation of at least 10 mm. | Procedure or surgery | Injectable TSFE |
| Implant placementAlso: implant insertionSimultaneous implant placement was performed when it was possible to achieve adequate primary stability in the residual crestal bone, otherwise crestal antrostomy was sealed by collagen sponges (Hemocollagene, Septodont, Saint-Maur-des-Fossés, France) and implant insertion was postponed. Flaps were sutured with Sentineri technique and single stitches using synthetic monofilament | Procedure or surgery | Injectable TSFE |
Primary outcome
implant survival
Time frame: 12 months
implant survival rate after one year of prosthetic loading
3 secondary outcomes
vertical bone gain
Time frame: six months
percentual graft shrinkage
Time frame: six months
occurrence of complications
Time frame: 12 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 29 Mar 2023.
- Results publication: PubMed 32233183Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part I. Sinus Floor Elevation: Biologic Principles and Materials. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e85-e93. doi: 10.11607/prd.4497.
- Results publication: PubMed 32233185Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part II. Surgical Techniques and Decision Tree. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e95-e102. doi: 10.11607/prd.4498.
- Derived from this study: PubMed 35867239Lombardi T, Lamazza L, Bernardello F, Zietek G, Stacchi C, Troiano G. Clinical and radiographic outcomes following transcrestal maxillary sinus floor elevation with injectable xenogenous bone substitute in gel form: a prospective multicenter study. Int J Implant Dent. 2022 Jul 22;8(1):32. doi: 10.1186/s40729-022-00431-5.
- Individual participant dataSharing planned: No. no sharing
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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.
Teresa Lombardi, Dr. principal investigator
International Piezoelectric Surgery Academy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Alveolar Ridge, run by International Piezosurgery Academy at 2 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 4 inclusion and 11 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 survival (time frame: 12 months). 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 NCT05305521, 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 29 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.