Edentulous JawNCT04662333
Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
A study testing Transcrestal approach for sinus lift and Xenograft application in people with Edentulous Jaw, run by University of Siena at 1 site in Italy.
Trial summary
Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Transcrestal approach for sinus lift and Xenograft application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 1 Mar 2023
- 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
- more than 18 years old
- edentulous in posterior maxilla
- patient in need of sinus augmentation procedure
- residual bone height greater than 3mm
Who cannot join
- systemic chronic diseases affecting osseointegration
- contraindication for implant therapy
- less than 18 years
- uncontrolled periodontitis
- smoker (more than 10 cig/day)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUS
Siena, 53100
Nicola Discepoli, ndiscepoli@me.com
About this study
Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups.
Control group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses.
Six months later, patients will be recalled for clinical and radiographic assessment.
Read the detailed description
Patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms.
Full-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion.
Crestal sinus lift with simultaneous implant placement will be performed in both groups.
Control group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of PEEK (poly-ether-ether-ketone).
Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium;
Resonance frequency analysis will be performed at the time of implant placement and at 1, 3, 6 months of follow-up.
Both healing abutment will be undersized: this characteristic will allow to harvest a 1mm-wide biopsy of the transmucosal tract at the end of the healing phase (6 months).
Six months after implant placement, impression will be taken and implants loaded with definitive screw-retained prostheses.
Six months later, patients will be recalled for clinical and radiographic assessment.
- Conditions
- Edentulous Jaw
- Being tested
- Transcrestal approach for sinus lift, Xenograft application
- Keywords
- Dental implant, Sinus lift, maxillary atrophy, biomaterials
- Medical subject headings
- Jaw, Edentulous, Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcrestal approach for sinus liftProcedure or surgery
After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.
Xenograft applicationProcedure or surgery
Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.
| Study group | Role | What they receive |
|---|---|---|
| Crestal sinus lift | Active comparator | Implant site preparation with detachment of Schneiderian membrane and subsequent implant placement. The corresponding healing abutment is made up of PEEK (poly-ether-ether-ketone) Receives: Procedure: Transcrestal approach for sinus lift |
| Crestal sinus lift with adjunctive xenograft | Experimental | Implant site preparation with detachment of Schneiderian membrane. After that, collagen membrane plus xenogenic bone substitute will be placed into the site before implant placement. The corresponding healing abutment is made up of titanium. Receives: Procedure: Transcrestal approach for sinus lift; Procedure: Xenograft application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications rate
amount of complications assessed at patient level
Measured: 12 months
Secondary outcomes (3)
Peri-implant bone stability
the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs
Measured: 12 months
Implant stability quotient
implant stability assessed by resonance frequency analysis
Measured: baseline, 1 month, 3 months, 6 months
Soft tissue inflammation
percentage of peri-implant soft tissue affected by inflamed connective tissue
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Oct 2020
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662333
- Sponsor's protocol ID
- CLS001
- Status last verified
- Dec 2020
- First submitted
- 29 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
- ClinicalTrials.gov ID
- NCT04662333
- Acronym / sponsor ID
- CLS001
- Conditions
- Edentulous Jaw
- Keywords
- Dental implant, Sinus lift, maxillary atrophy, biomaterials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 10 Dec 2020 (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.
Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups.
Control group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses.
Six months later, patients will be recalled for clinical and radiographic assessment.
Detailed description
Patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms.
Full-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion.
Crestal sinus lift with simultaneous implant placement will be performed in both groups.
Control group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of PEEK (poly-ether-ether-ketone).
Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium;
Resonance frequency analysis will be performed at the time of implant placement and at 1, 3, 6 months of follow-up.
Both healing abutment will be undersized: this characteristic will allow to harvest a 1mm-wide biopsy of the transmucosal tract at the end of the healing phase (6 months).
Six months after implant placement, impression will be taken and implants loaded with definitive screw-retained prostheses.
Six months later, patients will be recalled for clinical and radiographic assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crestal sinus lift | Active comparator | Procedure: Transcrestal approach for sinus liftImplant site preparation with detachment of Schneiderian membrane and subsequent implant placement. The corresponding healing abutment is made up of PEEK (poly-ether-ether-ketone) |
| Crestal sinus lift with adjunctive xenograft | Experimental | Procedure: Transcrestal approach for sinus lift, Procedure: Xenograft applicationImplant site preparation with detachment of Schneiderian membrane. After that, collagen membrane plus xenogenic bone substitute will be placed into the site before implant placement. The corresponding healing abutment is made up of titanium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more than 18 years old
- edentulous in posterior maxilla
- patient in need of sinus augmentation procedure
- residual bone height greater than 3mm
Key exclusion criteria (5 listed)
- systemic chronic diseases affecting osseointegration
- contraindication for implant therapy
- less than 18 years
- uncontrolled periodontitis
- smoker (more than 10 cig/day)
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 approach for sinus liftAfter surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part. | Procedure or surgery | Crestal sinus lift, Crestal sinus lift with adjunctive xenograft |
| Xenograft applicationBefore implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site. | Procedure or surgery | Crestal sinus lift with adjunctive xenograft |
Primary outcome
Complications rate
Time frame: 12 months
amount of complications assessed at patient level
3 secondary outcomes
Peri-implant bone stability
Time frame: 12 months
Implant stability quotient
Time frame: baseline, 1 month, 3 months, 6 months
Soft tissue inflammation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcrestal approach for sinus lift and Xenograft application in people with Edentulous Jaw, run by University of Siena 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 4 inclusion and 5 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 10 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola D Discepoli, Professor (3392491188, ndiscepoli@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications rate (time frame: 12 months). 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 10 Dec 2020.