Edentulous Alveolar RidgeNCT04111250
Crestal vs Lateral Sinus Lift Augmentation
A study testing Maxillary sinus augmentation in people with Edentulous Alveolar Ridge and Bone Atrophy, Alveolar, run by Hospital San Pietro Fatebenefratelli at 1 site in Albania.
Trial summary
The aim of this randomised controlled trial (RCT) of split-mouth design was to compare patient preference and effectiveness of two different techniques for lifting the maxillary sinus: the crestal approach versus the lateral window approach. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge, Bone Atrophy, Alveolar
- What is being tested?
- Maxillary sinus augmentation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAlbania
- Study dates
- 1 Nov 2015to 2 Apr 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Partially edentulous patient
- Bilateral edentulism in posterior maxillae (premolars and molars)
- 18 years or older
- Able to understand and sign an informed consent.
- At least 3 months after tooth extraction
- Vertical bone height at the implant sites between 2 to 6 mm
- Bone thickness at least 6 mm as measured on CBCT scan
Who cannot join
- general contraindications to implant surgery
- subjected to irradiation in the head and neck area
- immunosuppressed or immunocompromised
- treated or under treatment with intravenous amino-bisphosphonates
- poor oral hygiene and motivation
- untreated periodontal disease
Show all 15Show fewer
- uncontrolled diabetes
- pregnant or lactating
- substance abusers
- psychiatric problems
- unrealistic expectations
- lack of opposite occluding dentition/prosthesis
- acute or chronic infection/inflammation
- augmentation/implant placement
- referred only for implant placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Crestal Versus Lateral Sinus Lift: One-year Results From a Within-patient Randomised Controlled Trial
The aim of this randomised controlled trial (RCT) of split-mouth design was to compare patient preference and effectiveness of two different techniques for lifting the maxillary sinus: the crestal approach versus the lateral window approach.
Read the detailed description
Each patient having bilateral edentulism in posterior maxillae was randomised to receive one partial fixed prosthesis supported by one to three implants placed either with a crestal or with lateral window sinus lift procedure.
Eligibility criteria for participants
Only healed implant sites were considered (at least 3 months after tooth extraction). The vertical bone height at the implant sites to be included had to be between 2 to 6 mm and bone thickness at least 6 mm as measured on cone-bean computed tomography (CBCT) scans.
Patients were not admitted in the study if any of the following exclusion criteria was present:
general contraindications to implant surgery subjected to irradiation in the head and neck area immunosuppressed or immunocompromised treated or under treatment with intravenous amino-bisphosphonates poor oral hygiene and motivation untreated periodontal disease uncontrolled diabetes pregnant or lactating substance abusers psychiatric problems unrealistic expectations lack of opposite occluding dentition/prosthesis in the area intended for implant placement acute or chronic infection/inflammation in the area intended for sinus augmentation/implant placement referred only for implant placement who cannot be rehabilitated and followed at the treatment centre unable to attend a 5-year post-loading follow-up. Smokers were included and patients were categorised into three groups according to what declare: i) non-smokers; ìì) moderate smokers, if smoking up to 10 cigarettes/day; iii) heavy smokers if smoking more than 10 cigarettes/day.
Patients were recruited and treated in one private practice in Tirana, Albania by two operators: Marco Tallarico who performed all surgical interventions and Erta Xhanari who performed all prosthetic and maintenance procedures.
- Conditions
- Edentulous Alveolar Ridge, Bone Atrophy, Alveolar
- Being tested
- Maxillary sinus augmentation
- Keywords
- Dental implants, Maxillary sinus augmentation, Crestal approach
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary sinus augmentationProcedure or surgery
Also called Sinus lift
Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.
| Study group | Role | What they receive |
|---|---|---|
| Crestal sinus lift using iRasie implant | Experimental | Device: iRaise Sinus Lift implant (Maxillent, Herzliya, Israel). Procedure: crestal sinus lift augmentation.
We tested crestal versus lateral approach to the sinus. Crestal approach is made by a novel device (iRaise, implant system). Lateral approach is made conventionally with gold standard procedure (lateral approach).
The iRaise Sinus Lift implant is made of Titanium-6 Aluminum-4 Vanadium alloy, have a surface treated with grit blasting using an apatitic calcium phosphate media, followed by acid etching, and have an internal hexagon connection. Implants have an internal l-shape channel to allow saline and graft passage.
This implants system is made to perform crestal sinus lift procedure at the same time of the implant placement using the same device. After implant site preparation and initial implant placement, the hydraulic system is connected to the implant to allow the injection of saline and then graft the material. Then, the implant, is inserted for its full length. Receives: Procedure: Maxillary sinus augmentation |
| Lateral sinus lift | Active comparator | Conventional procedure.
Lateral approach to the sinus was made following the conventional procedure.
A window on the lateral wall of the sinus is performed according to a conventional surgical lateral approach to the sinus cavity. Graft materials is filled inside the sinus cavity. Finally, iSure implants [Maxillent] are placed, and flap is sutured. Receives: Procedure: Maxillary sinus augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis failure
Planned prosthesis which could not be placed due to implant failure(s), loss of the prosthesis secondary to implant failure(s) or a prosthesis that had to be remade for any reasons.
Measured: Up to 5 years
Implant failure
Implant mobility, removal of stable implants dictated by progressive marginal bone loss or infection, and implants fracture or any other mechanical complications rendering the implant unusable. The stability of each individual implant was measured with the removed prosthesis at abutment connection, at delivery definitive prostheses and at 1 year after loading, by tightening the implant abutment screws with a torque of 20 Ncm or by assessing the stability of individual crowns using the handles of two metallic instruments.
Measured: Up to 5 years
Complications
Any technical and biological complications
Measured: Up to 5 years
Patient's preference (questionnaire)
Answers: 1) the side treated with the crestal technique, 2) the side treated with the lateral technique, 3) none, both treatments were equally good, 4) none, both treatments were equally bad.
Measured: Assessed 1 week and 1 month after surgery
Secondary outcomes (2)
Time (minutes)
Time needs to perform the procedure, starting from the surgical incision to the delivery of the last suture, including the additional implants.
Measured: The time in minutes of the surgical procedure, from the incision of the gingiva to the placement of the last stitch
Marginal bone loss
Assessed on digital periapical radiographs taken with the paralleling technique at implant placement, prosthesis delivery and 1 year after loading using a digital apparatus (CS 2100, Carestream Dental, Rochester, NY, US). In the case of a not properly readable radiograph, the radiograph was to be taken again. Radiographs were stored in a TIFF format with a 600 dpi resolution, in a personal computer. Peri-implant marginal bone levels were measured using the DFW 2.8 software for windows (Soredex, Tuusula, Finland). The software was calibrated for every single image using the known implant diameter. The distance between marginal bone level and implant/abutment junction, was measured at both mesial and distal sides to the nearest 0.01 mm and averaged. Bone level changes at single implants was averaged at sinus level and then at group level. Reference points for the linear measurements were: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact.
Measured: 1 year after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Nov 2015
- Primary completion30 Mar 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split mouth design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Pietro Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tallarico, Hospital San Pietro Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111250
- Sponsor's protocol ID
- iRaise_RCT
- Status last verified
- Sep 2019
- First submitted
- 16 Jun 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Crestal Versus Lateral Sinus Lift: One-year Results From a Within-patient Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04111250
- Acronym / sponsor ID
- iRaise_RCT
- Conditions
- Edentulous Alveolar Ridge, Bone Atrophy, Alveolar
- Keywords
- Dental implants, Maxillary sinus augmentation, Crestal approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital San Pietro FatebenefratelliUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 1 Oct 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 aim of this randomised controlled trial (RCT) of split-mouth design was to compare patient preference and effectiveness of two different techniques for lifting the maxillary sinus: the crestal approach versus the lateral window approach.
Detailed description
Each patient having bilateral edentulism in posterior maxillae was randomised to receive one partial fixed prosthesis supported by one to three implants placed either with a crestal or with lateral window sinus lift procedure.
Eligibility criteria for participants
Only healed implant sites were considered (at least 3 months after tooth extraction). The vertical bone height at the implant sites to be included had to be between 2 to 6 mm and bone thickness at least 6 mm as measured on cone-bean computed tomography (CBCT) scans.
Patients were not admitted in the study if any of the following exclusion criteria was present:
general contraindications to implant surgery subjected to irradiation in the head and neck area immunosuppressed or immunocompromised treated or under treatment with intravenous amino-bisphosphonates poor oral hygiene and motivation untreated periodontal disease uncontrolled diabetes pregnant or lactating substance abusers psychiatric problems unrealistic expectations lack of opposite occluding dentition/prosthesis in the area intended for implant placement acute or chronic infection/inflammation in the area intended for sinus augmentation/implant placement referred only for implant placement who cannot be rehabilitated and followed at the treatment centre unable to attend a 5-year post-loading follow-up. Smokers were included and patients were categorised into three groups according to what declare: i) non-smokers; ìì) moderate smokers, if smoking up to 10 cigarettes/day; iii) heavy smokers if smoking more than 10 cigarettes/day.
Patients were recruited and treated in one private practice in Tirana, Albania by two operators: Marco Tallarico who performed all surgical interventions and Erta Xhanari who performed all prosthetic and maintenance procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth design
| Arm | Type | Receives |
|---|---|---|
| Crestal sinus lift using iRasie implant | Experimental | Procedure: Maxillary sinus augmentationDevice: iRaise Sinus Lift implant (Maxillent, Herzliya, Israel). Procedure: crestal sinus lift augmentation. We tested crestal versus lateral approach to the sinus. Crestal approach is made by a novel device (iRaise, implant system). Lateral approach is made conventionally with gold standard procedure (lateral approach). The iRaise Sinus Lift implant is made of Titanium-6 Aluminum-4 Vanadium alloy, have a surface treated with grit blasting using an apatitic calcium phosphate media, followed by acid etching, and have an internal hexagon connection. Implants have an internal l-shape channel to allow saline and graft passage. This implants system is made to perform crestal sinus lift procedure at the same time of the implant placement using the same device. After implant site preparation and initial implant placement, the hydraulic system is connected to the implant to allow the injection of saline and then graft the material. Then, the implant, is inserted for its full length. |
| Lateral sinus lift | Active comparator | Procedure: Maxillary sinus augmentationConventional procedure. Lateral approach to the sinus was made following the conventional procedure. A window on the lateral wall of the sinus is performed according to a conventional surgical lateral approach to the sinus cavity. Graft materials is filled inside the sinus cavity. Finally, iSure implants [Maxillent] are placed, and flap is sutured. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Partially edentulous patient
- Bilateral edentulism in posterior maxillae (premolars and molars)
- 18 years or older
- Able to understand and sign an informed consent.
- At least 3 months after tooth extraction
Key exclusion criteria (15 listed)
- general contraindications to implant surgery
- subjected to irradiation in the head and neck area
- immunosuppressed or immunocompromised
- treated or under treatment with intravenous amino-bisphosphonates
- poor oral hygiene and motivation
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 |
|---|---|---|
| Maxillary sinus augmentationAlso: Sinus liftRaise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement. | Procedure or surgery | Crestal sinus lift using iRasie implant, Lateral sinus lift |
Primary outcome
Prosthesis failure
Time frame: Up to 5 years
Planned prosthesis which could not be placed due to implant failure(s), loss of the prosthesis secondary to implant failure(s) or a prosthesis that had to be remade for any reasons.
Implant failure
Time frame: Up to 5 years
Implant mobility, removal of stable implants dictated by progressive marginal bone loss or infection, and implants fracture or any other mechanical complications rendering the implant unusable. The stability of each individual implant was measured with the removed prosthesis at abutment connection, at delivery definitive prostheses and at 1 year after loading, by tightening the implant abutment screws with a torque of 20 Ncm or by assessing the stability of individual crowns using the handles of two metallic instruments.
Complications
Time frame: Up to 5 years
Any technical and biological complications
Patient's preference (questionnaire)
Time frame: Assessed 1 week and 1 month after surgery
Answers: 1) the side treated with the crestal technique, 2) the side treated with the lateral technique, 3) none, both treatments were equally good, 4) none, both treatments were equally bad.
2 secondary outcomes
Time (minutes)
Time frame: The time in minutes of the surgical procedure, from the incision of the gingiva to the placement of the last stitch
Marginal bone loss
Time frame: 1 year after loading
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 1 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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 Maxillary sinus augmentation in people with Edentulous Alveolar Ridge and Bone Atrophy, Alveolar, run by Hospital San Pietro Fatebenefratelli at 1 site in Albania.
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 7 inclusion and 15 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 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 1 site in Albania. 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?
Prosthesis failure (time frame: Up to 5 years). The study lists 4 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 27 Oct 2026.