Bone Atrophy, AlveolarNCT05363306
Apico-coronal Position of Tissue-level Implants Bone Stability
An observational study of Bone Atrophy, Alveolar, run by International Piezosurgery Academy at 2 sites in Italy.
Trial summary
early marginal bone loss around dental implants may hamper long term prognosis of implant-prosthetic rehabilitation. this study aimed to study the correlation of pico-coronal position of dental implant (from supracrestal, crystal to undergone level) measuring early marginal bone loss through periapical x-ray at… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Atrophy, Alveolar
- What is being tested?
- implant insertion
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2021to 1 Mar 2022
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible
Who may be able to join
- Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible
- presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm;
- bone crest with at least 6mm of width and 9 mm of height above the mandibular canal without concomitant or previous bone augmentation procedures;
- presence of the opposing dentition
Who cannot join
- smokers
- uncontrolled periodontitis
- medication consumption for at least 3 months prior to treatment
- history of head or neck radiation therapy
- pregnancy or lactating at any time during the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Hesire
Cassano Allo Ionio, CS, 87011
Piezosurgery Academy
Parma, 43100
About this study
Official title: Influence of the Apico-coronal Position of Tissue-level Implants on Marginal Bone Stability
early marginal bone loss around dental implants may hamper long term prognosis of implant-prosthetic rehabilitation. this study aimed to study the correlation of pico-coronal position of dental implant (from supracrestal, crystal to undergone level) measuring early marginal bone loss through periapical x-ray at surgical time and subsequent follow-ups.
Read the detailed description
Early marginal bone loss (EMBL) is a non-infective remodeling process of peri-implant crestal bone occurring within the first year after implant insertion. EMBL has a multifactorial etiology, being influenced by various surgical and prosthetic factors, including insufficient crestal width, surgical trauma, biological width formation, microbial colonization of implant-abutment micro-gap, horizontal implant-abutment mismatch ("the platform-switching concept"), the number of abutment connection/disconnections, prosthetic abutment height, design and mechanical stability of implant-abutment connection and adaptive response to occlusal loading.
Biological width formation is the main factor influencing peri-implant marginal bone adaptive processes prior to prosthesis delivery. When an implant gets exposed to the oral cavity, soft tissues establish a cuff-like barrier sealing the trans-epithelial component of the fixture.
Differently from equicrestal and subcrestal implants, which present a microgap between implant and abutment at the marginal bone level, tissue-level implants have no gap at this region.
The present multicenter prospective study aims to evaluate if EMBL occurring around tissue-level dental implants before prosthesis delivery may be reduced by adapting apico-coronal positioning in relation to supracrestal tissue thickness.
All patients are treated according to one-stage implant. Sutures are removed 12-14 days after surgery. No removable prostheses are utilized during the healing period.
Final impressions were taken five months after the implant placement. After functional and aesthetic try-in, a single-unit screw-retained metal ceramic crown is delivered. The fixation screw was torqued to 30Ncm following manufacturer's guidelines. Screw access is then closed using light-cured composite resin.
Radiographic measurements. Digital radiographs, customized for each patient with a bite jig, are taken using a long-cone paralleling technique with a film holder at the time of implant placement (baseline, T0), 3 months after implant placement (T1), and 5 months after implant placement, immediately before impression taking (T2). All radiographs are performed using the same x-ray generator technology, set with the same parameters (60 kV, 7 mA).
Two different types of bone changes are calculated, as suggested elsewhere.
- Early marginal bone loss (EMBL) is calculated.
- Bone Loss Exposing Implant Surface (BLEIS) is calculated as the difference between the EMBL measurement and the 3 mm length of the transmucosal, machined portion of the implant.
Radiographs demonstrating any deformation, darkness and/or other problem are immediately repeated. All measurements are made by a single calibrated examiner, blind to mucosal thickness, using a 30-inch led-backlit color diagnostic display with Kodak Digital Imaging Software. Each measurement is repeated three times at three different time points as proposed by Gomez-Roman and Launer. Intra-examiner and inter-examiner concordances are 96.1% and 90.4%, respectively, for linear measurements within ±0.1mm.
- Conditions
- Bone Atrophy, Alveolar
- Being tested
- implant insertion
- Keywords
- osseointegrated implant; early marginal bone loss;
- 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 insertionProcedure or surgery
4% articaine solution, a mid-crestal incision along the center of the edentulous bone ridge was performed. A full-thickness flap was elevated. The sites were prepared to permit insertion of transmucosal, external hex, implants (I-smart, I-RES, Lugano, Switzerland) at three different crestal levels, based upon vertical mucosa thickness measured at implant placement.
Owing to width crest, all implants were 3.75 mm in diameter and operators selected appropriate implant lengths (8, 10 mm) according to available bone crest height. All implants were not submerged and flaps were sutured around the transmucosal component.
| Study group | Role | What they receive |
|---|---|---|
| thin crestal mucosa | Based upon vertical mucosa thickness measured at implant placement, implants were placed: 2mm below the crestal bone in presence of thin mucosa (< 2.5mm) Receives: Procedure: implant insertion | |
| medium crestal mucosa | Based upon vertical mucosa thickness measured at implant placement, implants were placed: 2) 1mm below the crestal bone in presence of medium mucosa (2.5-3.5mm); Receives: Procedure: implant insertion | |
| thick crestal mucosa | Based upon vertical mucosa thickness measured at implant placement, implants were placed: 1) at crestal level in presence of thick mucosa (> 3.5 mm); Receives: Procedure: implant insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
early marginal bone loss
distance from crystal bone to most coronal bone to implant contact
Measured: 5 months after implant placement
Secondary outcomes (1)
biological complications
any surgical complication
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone Atrophy, AlveolarStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Lombardi, Dr., Principal investigator, Hesire dental office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363306
- Sponsor's protocol ID
- TLMBS
- Status last verified
- May 2022
- First submitted
- 7 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lombardi T, Berton F, Salgarello S, Barbalonga E, Rapani A, Piovesana F, Gregorio C, Barbati G, Di Lenarda R, Stacchi C. Factors Influencing Early Marginal Bone Loss around Dental Implants Positioned Subcrestally: A Multicenter Prospective Clinical Study. J Clin Med. 2019 Aug 4;8(8):1168. doi: 10.3390/jcm8081168.
PubMed 31382675Spinato S, Bernardello F, Stacchi C, Soardi CM, Messina M, Rapani A, Lombardi T. Marginal Bone Changes Around Tissue-Level Implants After Prosthesis Delivery: A Multicenter Prospective Study. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70071. doi: 10.1111/cid.70071.
PubMed 40500982
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Apico-coronal Position of Tissue-level Implants on Marginal Bone Stability
- ClinicalTrials.gov ID
- NCT05363306
- Acronym / sponsor ID
- TLMBS
- Conditions
- Bone Atrophy, Alveolar
- Keywords
- osseointegrated implant; early marginal bone loss;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 5 May 2022 (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.
early marginal bone loss around dental implants may hamper long term prognosis of implant-prosthetic rehabilitation. this study aimed to study the correlation of pico-coronal position of dental implant (from supracrestal, crystal to undergone level) measuring early marginal bone loss through periapical x-ray at surgical time and subsequent follow-ups.
Detailed description
Early marginal bone loss (EMBL) is a non-infective remodeling process of peri-implant crestal bone occurring within the first year after implant insertion. EMBL has a multifactorial etiology, being influenced by various surgical and prosthetic factors, including insufficient crestal width, surgical trauma, biological width formation, microbial colonization of implant-abutment micro-gap, horizontal implant-abutment mismatch ("the platform-switching concept"), the number of abutment connection/disconnections, prosthetic abutment height, design and mechanical stability of implant-abutment connection and adaptive response to occlusal loading.
Biological width formation is the main factor influencing peri-implant marginal bone adaptive processes prior to prosthesis delivery. When an implant gets exposed to the oral cavity, soft tissues establish a cuff-like barrier sealing the trans-epithelial component of the fixture.
Differently from equicrestal and subcrestal implants, which present a microgap between implant and abutment at the marginal bone level, tissue-level implants have no gap at this region.
The present multicenter prospective study aims to evaluate if EMBL occurring around tissue-level dental implants before prosthesis delivery may be reduced by adapting apico-coronal positioning in relation to supracrestal tissue thickness.
All patients are treated according to one-stage implant. Sutures are removed 12-14 days after surgery. No removable prostheses are utilized during the healing period.
Final impressions were taken five months after the implant placement. After functional and aesthetic try-in, a single-unit screw-retained metal ceramic crown is delivered. The fixation screw was torqued to 30Ncm following manufacturer's guidelines. Screw access is then closed using light-cured composite resin.
Radiographic measurements. Digital radiographs, customized for each patient with a bite jig, are taken using a long-cone paralleling technique with a film holder at the time of implant placement (baseline, T0), 3 months after implant placement (T1), and 5 months after implant placement, immediately before impression taking (T2). All radiographs are performed using the same x-ray generator technology, set with the same parameters (60 kV, 7 mA).
Two different types of bone changes are calculated, as suggested elsewhere.
- Early marginal bone loss (EMBL) is calculated.
- Bone Loss Exposing Implant Surface (BLEIS) is calculated as the difference between the EMBL measurement and the 3 mm length of the transmucosal, machined portion of the implant.
Radiographs demonstrating any deformation, darkness and/or other problem are immediately repeated. All measurements are made by a single calibrated examiner, blind to mucosal thickness, using a 30-inch led-backlit color diagnostic display with Kodak Digital Imaging Software. Each measurement is repeated three times at three different time points as proposed by Gomez-Roman and Launer. Intra-examiner and inter-examiner concordances are 96.1% and 90.4%, respectively, for linear measurements within ±0.1mm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| thin crestal mucosa | – | Procedure: implant insertionBased upon vertical mucosa thickness measured at implant placement, implants were placed: 2mm below the crestal bone in presence of thin mucosa (< 2.5mm) |
| medium crestal mucosa | – | Procedure: implant insertionBased upon vertical mucosa thickness measured at implant placement, implants were placed: 2) 1mm below the crestal bone in presence of medium mucosa (2.5-3.5mm); |
| thick crestal mucosa | – | Procedure: implant insertionBased upon vertical mucosa thickness measured at implant placement, implants were placed: 1) at crestal level in presence of thick mucosa (> 3.5 mm); |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible
Key inclusion criteria (4 listed)
- Patients were partially edentulous and required placement of at least one single delayed implant in pristine bone in the posterior mandible
- presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm;
- bone crest with at least 6mm of width and 9 mm of height above the mandibular canal without concomitant or previous bone augmentation procedures;
- presence of the opposing dentition
Key exclusion criteria (5 listed)
- smokers
- uncontrolled periodontitis
- medication consumption for at least 3 months prior to treatment
- history of head or neck radiation therapy
- pregnancy or lactating at any time during the study
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 insertion4% articaine solution, a mid-crestal incision along the center of the edentulous bone ridge was performed. A full-thickness flap was elevated. The sites were prepared to permit insertion of transmucosal, external hex, implants (I-smart, I-RES, Lugano, Switzerland) at three different crestal levels, based upon vertical mucosa thickness measured at implant placement. Owing to width crest, all implants were 3.75 mm in diameter and operators selected appropriate implant lengths (8, 10 mm) according to available bone crest height. All implants were not submerged and flaps were sutured around the transmucosal component. | Procedure or surgery | medium crestal mucosa, thick crestal mucosa, thin crestal mucosa |
Primary outcome
early marginal bone loss
Time frame: 5 months after implant placement
distance from crystal bone to most coronal bone to implant contact
1 secondary outcome
biological complications
Time frame: during surgery
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 5 May 2022.
- Background: PubMed 31382675Lombardi T, Berton F, Salgarello S, Barbalonga E, Rapani A, Piovesana F, Gregorio C, Barbati G, Di Lenarda R, Stacchi C. Factors Influencing Early Marginal Bone Loss around Dental Implants Positioned Subcrestally: A Multicenter Prospective Clinical Study. J Clin Med. 2019 Aug 4;8(8):1168. doi: 10.3390/jcm8081168.
- Derived from this study: PubMed 40500982Spinato S, Bernardello F, Stacchi C, Soardi CM, Messina M, Rapani A, Lombardi T. Marginal Bone Changes Around Tissue-Level Implants After Prosthesis Delivery: A Multicenter Prospective Study. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70071. doi: 10.1111/cid.70071.
- Individual participant dataSharing planned: No
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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.
Teresa Lombardi, Dr. principal investigator
Hesire dental office
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Atrophy, Alveolar, run by International Piezosurgery Academy at 2 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 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: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
early marginal bone loss (time frame: 5 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 NCT05363306, which also lists 2 linked publications.
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 5 May 2022.