EdentulismNCT06759246
Short Implants in Atrophic Posterior Maxilla
A study testing implant placement in people with Edentulism and Bone Atrophy, Alveolar, run by University of Bari Aldo Moro at 1 site in Italy.
Trial summary
This study aims to evaluate the clinical and radiological outcomes of short implants in the rehabilitation of single-tooth edentulism in the posterior maxilla. By assessing these outcomes, the research seeks to determine the effectiveness and long-term viability of short implants as a minimally invasive solution… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulism, Bone Atrophy, Alveolar, Sinus Pneumatization
- What is being tested?
- implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 1 Nov 2024
- 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
- Good health status according to the classification system of the American Society of Anesthesiology (ASA), and patients were required to be 18 years of age or older.
- No general medical condition that would contraindicate implant therapy.
- No active periodontal disease, defined as a periodontal probing depth of less than 4 mm, or previously treated periodontitis.
- Good oral hygiene, with a full-mouth plaque index of less than 25%.
- Adequate control of inflammation, with a full-mouth bleeding on probing (BOP) of less than 25%.
Who cannot join
- Smoking more than 15 cigarettes per day
- Presence of untreated periodontal disease
- Pregnancy or breastfeeding at the time of enrollment
- Active infections
- Less than 2 mm of keratinized mucosal tissue.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Implant Placement for Single-Tooth Rehabilitation in the Atrophic Posterior Maxilla
This study aims to evaluate the clinical and radiological outcomes of short implants in the rehabilitation of single-tooth edentulism in the posterior maxilla. By assessing these outcomes, the research seeks to determine the effectiveness and long-term viability of short implants as a minimally invasive solution, particularly in cases where bone height is limited.
Read the detailed description
The present municentric retrospective study was conducted following the STROBE statement recommendations for observational studies and in compliance to the principles of the Declaration of Helsinki on clinical research involving human subjects.The study aims to evaluate short implants placed over the past 15 years by three experienced clinicians, assessing their survival and clinical success. Specifically, the study collects clinical data such as probing depth, the presence or absence of peri-implantitis, and radiological findings.
- Conditions
- Edentulism, Bone Atrophy, Alveolar, Sinus Pneumatization
- Being tested
- implant placement
- Keywords
- short implants, bone atrophy, sinus pneumatization, minimal invasive
- 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.
implant placementProcedure or surgery
Placement of short implants for the rehabilitation of single-tooth edentulism in atrophic maxillae near the maxillary sinus.
| Study group | Role | What they receive |
|---|---|---|
| Atrophic maxillae | Other | A group of patients with atrophic maxillae requiring rehabilitation for single-tooth edentulism. Receives: Procedure: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Survival rate: A statistical analysis will be conducted to evaluate the implant survival rate at three specific time points: T1 (3 months), T2 (6 months), and T3 (2 years).
Measured: 2 years
Secondary outcomes (1)
Rx outcome
Radiographic measurements will be obtained using standardized imaging techniques. The measurements will be performed digitally using dedicated three-dimensional radiological imaging software, ensuring high precision. Distances will be measured in millimeters to evaluate implant positioning, bone levels, and defect morphology with accuracy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2014
- Primary completion1 Sep 2024
- Study completion1 Nov 2024
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 EdentulismStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, University of Bari Aldo Moro
- Investigators
- Professor Saverio Capodiferro, Study director, University of Bari Aldo MoroProfessor Massimo Corsalini, Study director, University of Bari Aldo MoroDr. D'Albis Giuseppe, Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759246
- Sponsor's protocol ID
- Implants01
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Corsalini M, D'Agostino S, Favia G, Dolci M, Tempesta A, Di Venere D, Limongelli L, Capodiferro S. A Minimally Invasive Technique for Short Spiral Implant Insertion with Contextual Crestal Sinus Lifting in the Atrophic Maxilla: A Preliminary Report. Healthcare (Basel). 2020 Dec 24;9(1):11. doi: 10.3390/healthcare9010011.
PubMed 33374157
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Implant Placement for Single-Tooth Rehabilitation in the Atrophic Posterior Maxilla
- ClinicalTrials.gov ID
- NCT06759246
- Acronym / sponsor ID
- Implants01
- Conditions
- Edentulism, Bone Atrophy, Alveolar, Sinus Pneumatization
- Keywords
- short implants, bone atrophy, sinus pneumatization, minimal invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 6 Jan 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.
This study aims to evaluate the clinical and radiological outcomes of short implants in the rehabilitation of single-tooth edentulism in the posterior maxilla. By assessing these outcomes, the research seeks to determine the effectiveness and long-term viability of short implants as a minimally invasive solution, particularly in cases where bone height is limited.
Detailed description
The present municentric retrospective study was conducted following the STROBE statement recommendations for observational studies and in compliance to the principles of the Declaration of Helsinki on clinical research involving human subjects.The study aims to evaluate short implants placed over the past 15 years by three experienced clinicians, assessing their survival and clinical success. Specifically, the study collects clinical data such as probing depth, the presence or absence of peri-implantitis, and radiological findings.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrophic maxillae | Other | Procedure: implant placementA group of patients with atrophic maxillae requiring rehabilitation for single-tooth edentulism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Good health status according to the classification system of the American Society of Anesthesiology (ASA), and patients were required to be 18 years of age or older.
- No general medical condition that would contraindicate implant therapy.
- No active periodontal disease, defined as a periodontal probing depth of less than 4 mm, or previously treated periodontitis.
- Good oral hygiene, with a full-mouth plaque index of less than 25%.
- Adequate control of inflammation, with a full-mouth bleeding on probing (BOP) of less than 25%.
Key exclusion criteria (5 listed)
- Smoking more than 15 cigarettes per day
- Presence of untreated periodontal disease
- Pregnancy or breastfeeding at the time of enrollment
- Active infections
- Less than 2 mm of keratinized mucosal tissue.
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 |
|---|---|---|
| implant placementPlacement of short implants for the rehabilitation of single-tooth edentulism in atrophic maxillae near the maxillary sinus. | Procedure or surgery | Atrophic maxillae |
Primary outcome
Clinical outcome
Time frame: 2 years
Survival rate: A statistical analysis will be conducted to evaluate the implant survival rate at three specific time points: T1 (3 months), T2 (6 months), and T3 (2 years).
1 secondary outcome
Rx outcome
Time frame: 2 years
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 7 Jan 2025.
- Results publication: PubMed 33374157Corsalini M, D'Agostino S, Favia G, Dolci M, Tempesta A, Di Venere D, Limongelli L, Capodiferro S. A Minimally Invasive Technique for Short Spiral Implant Insertion with Contextual Crestal Sinus Lifting in the Atrophic Maxilla: A Preliminary Report. Healthcare (Basel). 2020 Dec 24;9(1):11. doi: 10.3390/healthcare9010011.
- 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.
Professor Saverio Capodiferro study director
University of Bari Aldo Moro
Professor Massimo Corsalini study director
University of Bari Aldo Moro
Dr. D'Albis Giuseppe principal investigator
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement in people with Edentulism and Bone Atrophy, Alveolar, run by University of Bari Aldo Moro 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 5 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: finished, as of the sponsor's last update on 7 Jan 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?
Clinical outcome (time frame: 2 years). 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 NCT06759246, 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 7 Jan 2025.