Peri-Implantation LossNCT05766878
The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics
A study testing implants placement in people with Peri-Implantation Loss and Periodontal Bone Loss, run by University of Foggia at 3 sites in Italy.
Trial summary
The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantation Loss, Periodontal Bone Loss, Periimplantitis
- What is being tested?
- implants placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesItaly
- Study dates
- 9 Jun 2023to 17 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants;
- at least 6 month after extraction;
Who cannot join
- post-extractive implants;
- sites requiring bone regeneration or maxillary sinus lift;
- general health problems that contraindicate implant treatment.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Clinica Odontoiatrica, University of Foggia
Foggia, 71122
University of Genoa
Genova
University of Turin
Torino, 10121
About this study
Official title: The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics: Multicentric RCT
The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.
- Conditions
- Peri-Implantation Loss, Periodontal Bone Loss, Periimplantitis, Gingival Inflammation, Implant Complication, Osseointegration Failure of Dental Implant
- Being tested
- implants placement
- Keywords
- short implants, surface treatment
- Medical subject headings
- Alveolar Bone Loss, Peri-Implantitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implants placementDevice
The intervention will consist of placement of two types of short implants (one with traditional machined collar and one with anodized collar). After their healing period, the prosthetic rehabilitation will be made.
| Study group | Role | What they receive |
|---|---|---|
| machined collar | Active comparator | The arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement.
A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and traditional machined collar. A definitive transgingival standard machined abutment will be immediately screwed. Four months later, prosthetic procedures will start. Receives: Device: implants placement |
| anodized collar | Experimental | The arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement.
A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and anodized collar. A definitive transgingival anodized abutment will be immediately screwed. Four months later, prosthetic procedures will start. Receives: Device: implants placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone remodeling around the implant
The marginal bone remodeling will be evaluated by Radiographic examination. Periapical radiographs will be performed using paralleling technique with a Rinn-type positioner, customized for each patient at implant placement (T0), prosthetic restoration delivery (T1), and after 12 months (T2).Peri-implant bone levels will be measured at each time point as the linear distance (in mm) between implant platform and bone crest at mesial and distal aspects of each implant. A positive value will be assigned if the bone crest is coronal to the implant platform, whereas a negative value will be assigned if the first bone-to implant contact is apical to the implant platform. All measurements will be performed by two examiners, using measuring software (Image J). Each measurement will be performed three times at three different points.
Measured: 0-4-12 months after implant placement
Secondary outcomes (5)
Periodontal indexes: Probing Depth
Probing Depth (PD) will be calculated as the distance (in mm) from the gingival peri-implant margin to the bottom of the peri-implant pocket.
Measured: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Implant Stability evaluation
Primary and secondary implant stability will be measured with resonance frequency analysis (RFA) and subsequently expressed as an implant stability quotient (ISQ). The Implant stability will be measured immediately after placement (T0) and at 4 months (T1) after placement, when the osseointegration is supposed to take place.
Measured: 0-4 months.
Bleeding on Probing
Bleeding on probing (BoP) will be scored dichotomously (Yes/No). The probing will be performed on 6 sites around the implant (3 buccal and 3 palatal/lingual) and appearance of blood will be registered (Yes). The final score will be expressed as number of bleeding sites/total of probed sites (%)
Measured: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Suppuration on probing
Suppuration on probing (SUP) will be scored dichotomously (Yes/No). The probing will be performed on 6 sites around the implant (3 buccal and 3 palatal/lingual) and appearance of pus or purulent exudate will be registered (Yes). The final score will be expressed as number of suppurative sites/total of probed sites (%)
Measured: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Plaque index of peri-implant tissues
Plaque Index (PI) will be calculated by assigning a binary score to each surface (1= plaque present, 0 = plaque absent).
Measured: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start9 Jun 2023
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
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 Peri-Implantation LossStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Collaborators
- Universita degli Studi di Genova, University of Turin, Italy
- Responsible party
- Principal investigator, Khrystyna Zhurakivska, University of Foggia
- Investigators
- Giuseppe Troiano, DDS, PhD, Principal investigator, University of FoggiaFrancesco Pera, DDS, PhD, Study chair, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766878
- Sponsor's protocol ID
- SHORT_1
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data, in compliance with the privacy protection rules, will be shared upon request.
Publications
Longhi B, Pera F, Menini M, Bagnasco F, Pesce P, Caroprese M, Troiano G, Zhurakivska K. The Influence of Implant Surface Modification on Marginal Bone Loss and Periodontal Health: A Cross-Over Randomized Clinical Trial. Int J Dent. 2025 Sep 28;2025:8889144. doi: 10.1155/ijod/8889144. eCollection 2025.
PubMed 41059354
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics: Multicentric RCT
- ClinicalTrials.gov ID
- NCT05766878
- Acronym / sponsor ID
- SHORT_1
- Conditions
- Peri-Implantation Loss, Periodontal Bone Loss, Periimplantitis, Gingival Inflammation, Implant Complication, Osseointegration Failure of Dental Implant
- Keywords
- short implants, surface treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Collaborators
- Universita degli Studi di Genova, University of Turin, Italy
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 13 Mar 2023 (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 the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| machined collar | Active comparator | Device: implants placementThe arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement. A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and traditional machined collar. A definitive transgingival standard machined abutment will be immediately screwed. Four months later, prosthetic procedures will start. |
| anodized collar | Experimental | Device: implants placementThe arm will be constituted by healthy people, that need to be rehabilitated by dental implant placement. A short implant (length 6mm; diameter 4.3) will be inserted in an edentulous site. The implant will present a surface treated with double acid etching and anodized collar. A definitive transgingival anodized abutment will be immediately screwed. Four months later, prosthetic procedures will start. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants;
- at least 6 month after extraction;
Key exclusion criteria (3 listed)
- post-extractive implants;
- sites requiring bone regeneration or maxillary sinus lift;
- general health problems that contraindicate implant treatment.
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 |
|---|---|---|
| implants placementThe intervention will consist of placement of two types of short implants (one with traditional machined collar and one with anodized collar). After their healing period, the prosthetic rehabilitation will be made. | Device | anodized collar, machined collar |
Primary outcome
Marginal Bone remodeling around the implant
Time frame: 0-4-12 months after implant placement
The marginal bone remodeling will be evaluated by Radiographic examination. Periapical radiographs will be performed using paralleling technique with a Rinn-type positioner, customized for each patient at implant placement (T0), prosthetic restoration delivery (T1), and after 12 months (T2).Peri-implant bone levels will be measured at each time point as the linear distance (in mm) between implant platform and bone crest at mesial and distal aspects of each implant. A positive value will be assigned if the bone crest is coronal to the implant platform, whereas a negative value will be assigned if the first bone-to implant contact is apical to the implant platform. All measurements will be performed by two examiners, using measuring software (Image J). Each measurement will be performed three times at three different points.
5 secondary outcomes
Periodontal indexes: Probing Depth
Time frame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Implant Stability evaluation
Time frame: 0-4 months.
Bleeding on Probing
Time frame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Suppuration on probing
Time frame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
Plaque index of peri-implant tissues
Time frame: The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.
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 19 Feb 2025.
- Derived from this study: PubMed 41059354Longhi B, Pera F, Menini M, Bagnasco F, Pesce P, Caroprese M, Troiano G, Zhurakivska K. The Influence of Implant Surface Modification on Marginal Bone Loss and Periodontal Health: A Cross-Over Randomized Clinical Trial. Int J Dent. 2025 Sep 28;2025:8889144. doi: 10.1155/ijod/8889144. eCollection 2025.
- Individual participant dataSharing planned: No. The data, in compliance with the privacy protection rules, will be shared upon request.
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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.
Giuseppe Troiano, DDS, PhD principal investigator
University of Foggia
Francesco Pera, DDS, PhD study chair
University of Turin, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implants placement in people with Peri-Implantation Loss and Periodontal Bone Loss, run by University of Foggia at 3 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 2 inclusion and 3 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Marginal Bone remodeling around the implant (time frame: 0-4-12 months after implant placement). 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 NCT05766878, 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 19 Feb 2025.