Sinus LiftTSLNCT07041411
Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen
A study testing maxillary sinus elevation through transcrestal approach using OSSIX® Bone in people with Sinus Lift and Graft Materials, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site in Italy.
Trial summary
Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla. Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Lift, Graft Materials, Transcrestal Approach
- What is being tested?
- maxillary sinus elevation through transcrestal approach using OSSIX® Bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 10 Nov 2022to 22 Mar 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient requiring vertical elevation of the maxillary sinus.
- Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of < 3-4 mm.
- Males and females between 30-80 years old
- Patients with healthy periodontal conditions (Treated periodontitis, Plaque Index (PI) <25%, Bleeding on Probing (BoP) <25%).
- Patients that are willing to sign an informed consent and participate in a clinical Study.
- Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
- Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.
Who cannot join
- Patient requiring vertical elevation of the maxillary sinus with native bone crest height > 5 mm
- Patients who smoke over 5 cigarettes/day
- Pregnancy (confirmed by verbal inquiry)
- Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
- Patients taking bisphosphonates
- Any sites where an implant already failed sites
Show all 16Show fewer
- Untreated Periodontitis
- Dental sites with acute infections
- Chronic inflammatory diseases of the oral cavity
- Autoimmune diseases (cortisone intake)
- Allergy declared to one or more medicaments to be used during treatment
- Alcoholics patients and/or drug addicts
- Patients with known collagen hypersensitivity.
- Patients with sensitivity to porcine-derived materials.
- History or malignant tumors of the maxillary sinus
- History of local radiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological and Radiological Evaluation of Crosslinked vs Not Cross Linked Graft in Transcretal Sinus Elevation in Severely Resorbed Maxilla. A Prospective, Controlled Study
Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla.
Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. clinical study of 20 patients 13 in OSSIX Bone group 13 in Bio-Oss Collagen group all patients requiring a regenerative procedure (sinus lift) having less than 3mm of residual bone height (RBH) with the impossibility to place the implants at the time of regenerative proc 6 months follow up for the first endpoint. (collection of the histological sample) 12 months follow up - long term clinical evaluation. tests performed: Cone Beam Computed Tomography (CBCT), clinical evaluation, X-ray
Read the detailed description
Visit 1 - Screening Visit - preoperative visit (informed consent, dental mouth cleaning, CBCT, intraoral scanning).
Visit 2 - Baseline visit - T0 (surgical procedure) Sinus elevation with OSSIX® Bone or Bio-Oss® Collagen, periapical x-ray, intraoral photo with microscope.
Visit 3 - Follow up visit - 14 days - suture removal, clinical evaluation and patient satisfaction questionnaire.
Visit 4 - Follow up visit - 180days (One week before) Cone Beam Computed Tomography (CBCT), Dental mouth cleaning, intraoral scanning.
(Second surgery) implant site preparation and histological sample collection, implant placement, insertion torque value, implant stability, peri-apical x-ray, intraoral scanning and photography.
Visit 5 - Follow up visit - 194 days suture removal and clinical evaluation. Visit 6 - Follow up visit - 270 days Implant stability, clinical examination, definitive restoration and periapical x-ray Visit 7- Follow up visit - 365 days Implant stability, peri-apical x-ray, definitive restoration, Cone Beam Computed Tomography (CBCT), intraoral scanning and picture.
- Conditions
- Sinus Lift, Graft Materials, Transcrestal Approach
- Being tested
- maxillary sinus elevation through transcrestal approach using OSSIX® Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary sinus elevation through transcrestal approach using OSSIX® BoneProcedure or surgery
Also called maxillary sinus elevation through transcrestal approach using Bio-Oss® Bone, Ossix Bone
After a careful radiologic analysis, using a surgical guide, maxillary sinus elevation through transcrestal access to sinus mucosa was achieved. The elevation of the maxillary sinus mucosa was performed through micro-elevators and graft material was inserted.
| Study group | Role | What they receive |
|---|---|---|
| OSSIX Bone | Experimental | OSSIX® Bone in the maxillary sinus elevation. Receives: Procedure: maxillary sinus elevation through transcrestal approach using OSSIX® Bone |
| Bio-Oss collagen | Active comparator | Bio-Oss Collagen in the maxillary sinus elevation. Receives: Procedure: maxillary sinus elevation through transcrestal approach using OSSIX® Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological analysis
samples were collected and histologically and immunohistologically analyzed
Measured: 6 months after graft insertion
Secondary outcomes (1)
radiological analyis
preoperatively Cone Beam Computed Tomography (CBCT) was compared to 12 months CBCT. The volume of bone regeneration was measured by performing a semi-automatic segmentation using a specific segmentation software (3D Slicer) and measured in mm3.
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 posted27 Jun 2025
- Study start10 Nov 2022
- Primary completion2 May 2024
- Study completion22 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus LiftStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- controlled clinical investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Canullo, Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041411
- Sponsor's protocol ID
- dontiart
- Acronym
- TSL
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be shared if required
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Radiological Evaluation of Crosslinked vs Not Cross Linked Graft in Transcretal Sinus Elevation in Severely Resorbed Maxilla. A Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT07041411
- Acronym / sponsor ID
- TSL / dontiart
- Conditions
- Sinus Lift, Graft Materials, Transcrestal Approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. CanulloUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 27 Jun 2025 (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.
Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla.
Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. clinical study of 20 patients 13 in OSSIX Bone group 13 in Bio-Oss Collagen group all patients requiring a regenerative procedure (sinus lift) having less than 3mm of residual bone height (RBH) with the impossibility to place the implants at the time of regenerative proc 6 months follow up for the first endpoint. (collection of the histological sample) 12 months follow up - long term clinical evaluation. tests performed: Cone Beam Computed Tomography (CBCT), clinical evaluation, X-ray
Detailed description
Visit 1 - Screening Visit - preoperative visit (informed consent, dental mouth cleaning, CBCT, intraoral scanning).
Visit 2 - Baseline visit - T0 (surgical procedure) Sinus elevation with OSSIX® Bone or Bio-Oss® Collagen, periapical x-ray, intraoral photo with microscope.
Visit 3 - Follow up visit - 14 days - suture removal, clinical evaluation and patient satisfaction questionnaire.
Visit 4 - Follow up visit - 180days (One week before) Cone Beam Computed Tomography (CBCT), Dental mouth cleaning, intraoral scanning.
(Second surgery) implant site preparation and histological sample collection, implant placement, insertion torque value, implant stability, peri-apical x-ray, intraoral scanning and photography.
Visit 5 - Follow up visit - 194 days suture removal and clinical evaluation. Visit 6 - Follow up visit - 270 days Implant stability, clinical examination, definitive restoration and periapical x-ray Visit 7- Follow up visit - 365 days Implant stability, peri-apical x-ray, definitive restoration, Cone Beam Computed Tomography (CBCT), intraoral scanning and picture.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- controlled clinical investigation
| Arm | Type | Receives |
|---|---|---|
| OSSIX Bone | Experimental | Procedure: maxillary sinus elevation through transcrestal approach using OSSIX® BoneOSSIX® Bone in the maxillary sinus elevation. |
| Bio-Oss collagen | Active comparator | Procedure: maxillary sinus elevation through transcrestal approach using OSSIX® BoneBio-Oss Collagen in the maxillary sinus elevation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient requiring vertical elevation of the maxillary sinus.
- Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of < 3-4 mm.
- Males and females between 30-80 years old
- Patients with healthy periodontal conditions (Treated periodontitis, Plaque Index (PI) <25%, Bleeding on Probing (BoP) <25%).
- Patients that are willing to sign an informed consent and participate in a clinical Study.
Key exclusion criteria (16 listed)
- Patient requiring vertical elevation of the maxillary sinus with native bone crest height > 5 mm
- Patients who smoke over 5 cigarettes/day
- Pregnancy (confirmed by verbal inquiry)
- Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
- Patients taking bisphosphonates
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 elevation through transcrestal approach using OSSIX® BoneAlso: maxillary sinus elevation through transcrestal approach using Bio-Oss® Bone, Ossix BoneAfter a careful radiologic analysis, using a surgical guide, maxillary sinus elevation through transcrestal access to sinus mucosa was achieved. The elevation of the maxillary sinus mucosa was performed through micro-elevators and graft material was inserted. | Procedure or surgery | Bio-Oss collagen, OSSIX Bone |
Primary outcome
histological analysis
Time frame: 6 months after graft insertion
samples were collected and histologically and immunohistologically analyzed
1 secondary outcome
radiological analyis
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 27 Jun 2025.
- Individual participant dataSharing planned: No. data will be shared if required
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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 elevation through transcrestal approach using OSSIX® Bone in people with Sinus Lift and Graft Materials, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site 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 7 inclusion and 16 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 27 Jun 2025. 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 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?
histological analysis (time frame: 6 months after graft insertion). 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 27 Jun 2025.