Alveolar Bone LossNCT05494476
Stability of the Marginal Bone Around Subcrestal Implants
A study testing implant insertion in people with Alveolar Bone Loss and Dental Implant Failure Nos, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success. Apico-coronal position represents a crucial factor in this field. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Dental Implant Failure Nos
- What is being tested?
- implant insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 23 Oct 2020to 15 Jul 2022
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indications for the insertion of two implants in a free edentulous ridge in the posterior area of both arches (premolar / molar area), based on a careful diagnosis and treatment plan;
- presence of a residual bone crest with a minimum surgical height of 9 mm, and a thickness of at least 6 mm at the level of the planned implant sites;
- the bone crest must be healed (at least 6 months after tooth loss / extraction of the corresponding dental element);
- native bone;
- plaque index below 25% and bleeding index below 20%;
- facial-lingual width of the adherent gingiva ≥ 4 mm;
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- age of the patient> 18 years;
- patients must be able to review and understand the study protocol;
- informed consent.
Who cannot join
- acute myocardial infarction within the last 6 months;
- uncompensated coagulation disorders;
- uncontrolled diabetes (HbA1c> 7.5%);
- head / neck radiotherapy in the last 24 months;
- immunocompromised patients (HIV infection or chemotherapy within the last 5 years);
- present or past treatment with antiresorptive drugs;
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- psychological or psychiatric problems;
- alcohol or drug abuse;
- presence of uncontrolled periodontal disease
- acute and chronic endodontic infections next to implant site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stability of the Marginal Bone Around Subcrestal Implants Inserted at Different Depths. A Multicenter Clinical Study
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success. Apico-coronal position represents a crucial factor in this field. This study aims to establish the optimal insertion depth of a subcrestal implant, with the aim of minimizing the bone resorption.
Read the detailed description
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success.
In reality, the etiology of this bone remodeling (Marginal Bone Loss-MBL) has not yet been well understood, although many theories have been proposed to explain it.
The influence of mucosal thickness on marginal bone loss has been discussed by Cochran et al., which suggest a protective action for the underlying soft tissue bone that recreates a sort of "biological width" around the implant. In fact, some studies have hypothesized that a marginal bone loss> 2.0 mm provides the vertical space for the correct restoration of biological width. Linkevicius et al. have published various studies that have shown that, in crestally placed implants with switching platform, a vertical thickness of the soft tissues greater than 2 mm is effective in preventing the loss of peri-implant marginal bone. However, other authors have demonstrated significant marginal bone loss around implants with low prosthetic abutments compared to those with higher prosthetic abutments. In particular, the extent of bone loss was more reduced when the height of the abutment was> 2 mm. From a theoretical point of view, a 3 mm high prosthetic abutment, calculated from the apical edge of the crown to the implant platform, should provide adequate space for restoring biological width.
Furthermore, a recent study conducted on subcrestal implants has shown that early marginal bone resorption, in addition to being linked to the thickness of the soft tissues and the height of the abutment, is negatively influenced by the depth of implant insertion. However, the same study underlines that implants inserted more deeply, while losing more marginal bone than more superficial implants, are covered by a greater bone thickness at the end of the remodeling process.
This study aims to establish the optimal insertion depth of a subcrestal implant, with the aim of minimizing the resorption of the marginal bone and keeping the implant platform below the bone level after 12 months of prosthetic loading.
- Conditions
- Alveolar Bone Loss, Dental Implant Failure Nos
- Being tested
- implant insertion
- Keywords
- marginal bone loss, peri-implant bone remodeling, submerged dental implant
- 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
after flap detachment, implant bed will be prepared with twist-drill, implant will be inserted according to randomization (1 or 2 mm under bone)
| Study group | Role | What they receive |
|---|---|---|
| 2mm under bone level | Active comparator | implant platform will be submerged 2mm under bone level Receives: Procedure: implant insertion |
| 1mm under bone level | Active comparator | implant platform will be submerged 1mm under bone level Receives: Procedure: implant insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
radiographic assessment
Measured: at implant insertion
marginal bone loss
radiographic assessment
Measured: 5 month after implant insertion
marginal bone loss
radiographic assessment
Measured: 6 months after prosthetic loading
marginal bone loss
radiographic assessment
Measured: 12 months after prosthetic loading
marginal bone loss
radiographic assessment
Measured: 3 years after prosthetic loading
marginal bone loss
radiographic assessment
Measured: 5 years after prosthetic loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start23 Oct 2020
- Primary completion15 Dec 2021
- Study completion15 Jul 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 Alveolar Bone 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth protocol
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Trieste
- Responsible party
- Sponsor
- Investigators
- Claudio Stacchi, Dr, Study director, Piezoelectric Surgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494476
- Sponsor's protocol ID
- MEGADEPTH
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spinato S, Stacchi C, Lombardi T, Bernardello F, Messina M, Zaffe D. Biological width establishment around dental implants is influenced by abutment height irrespective of vertical mucosal thickness: A cluster randomized controlled trial. Clin Oral Implants Res. 2019 Jul;30(7):649-659. doi: 10.1111/clr.13450. Epub 2019 May 12.
PubMed 31033035Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11.
PubMed 25678247
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of the Marginal Bone Around Subcrestal Implants Inserted at Different Depths. A Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT05494476
- Acronym / sponsor ID
- MEGADEPTH
- Conditions
- Alveolar Bone Loss, Dental Implant Failure Nos
- Keywords
- marginal bone loss, peri-implant bone remodeling, submerged dental implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Collaborators
- University of Trieste
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 10 Aug 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.
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success. Apico-coronal position represents a crucial factor in this field. This study aims to establish the optimal insertion depth of a subcrestal implant, with the aim of minimizing the bone resorption.
Detailed description
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success.
In reality, the etiology of this bone remodeling (Marginal Bone Loss-MBL) has not yet been well understood, although many theories have been proposed to explain it.
The influence of mucosal thickness on marginal bone loss has been discussed by Cochran et al., which suggest a protective action for the underlying soft tissue bone that recreates a sort of "biological width" around the implant. In fact, some studies have hypothesized that a marginal bone loss> 2.0 mm provides the vertical space for the correct restoration of biological width. Linkevicius et al. have published various studies that have shown that, in crestally placed implants with switching platform, a vertical thickness of the soft tissues greater than 2 mm is effective in preventing the loss of peri-implant marginal bone. However, other authors have demonstrated significant marginal bone loss around implants with low prosthetic abutments compared to those with higher prosthetic abutments. In particular, the extent of bone loss was more reduced when the height of the abutment was> 2 mm. From a theoretical point of view, a 3 mm high prosthetic abutment, calculated from the apical edge of the crown to the implant platform, should provide adequate space for restoring biological width.
Furthermore, a recent study conducted on subcrestal implants has shown that early marginal bone resorption, in addition to being linked to the thickness of the soft tissues and the height of the abutment, is negatively influenced by the depth of implant insertion. However, the same study underlines that implants inserted more deeply, while losing more marginal bone than more superficial implants, are covered by a greater bone thickness at the end of the remodeling process.
This study aims to establish the optimal insertion depth of a subcrestal implant, with the aim of minimizing the resorption of the marginal bone and keeping the implant platform below the bone level after 12 months of prosthetic loading.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- split mouth protocol
| Arm | Type | Receives |
|---|---|---|
| 2mm under bone level | Active comparator | Procedure: implant insertionimplant platform will be submerged 2mm under bone level |
| 1mm under bone level | Active comparator | Procedure: implant insertionimplant platform will be submerged 1mm under bone level |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- indications for the insertion of two implants in a free edentulous ridge in the posterior area of both arches (premolar / molar area), based on a careful diagnosis and treatment plan;
- presence of a residual bone crest with a minimum surgical height of 9 mm, and a thickness of at least 6 mm at the level of the planned implant sites;
- the bone crest must be healed (at least 6 months after tooth loss / extraction of the corresponding dental element);
- native bone;
- plaque index below 25% and bleeding index below 20%;
Key exclusion criteria (10 listed)
- acute myocardial infarction within the last 6 months;
- uncompensated coagulation disorders;
- uncontrolled diabetes (HbA1c> 7.5%);
- head / neck radiotherapy in the last 24 months;
- immunocompromised patients (HIV infection or chemotherapy within the last 5 years);
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 insertionafter flap detachment, implant bed will be prepared with twist-drill, implant will be inserted according to randomization (1 or 2 mm under bone) | Procedure or surgery | 1mm under bone level, 2mm under bone level |
Primary outcome
marginal bone loss
Time frame: at implant insertion
radiographic assessment
marginal bone loss
Time frame: 5 month after implant insertion
radiographic assessment
marginal bone loss
Time frame: 6 months after prosthetic loading
radiographic assessment
marginal bone loss
Time frame: 12 months after prosthetic loading
radiographic assessment
marginal bone loss
Time frame: 3 years after prosthetic loading
radiographic assessment
marginal bone loss
Time frame: 5 years after prosthetic loading
radiographic assessment
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 10 Aug 2022.
- Background: PubMed 31033035Spinato S, Stacchi C, Lombardi T, Bernardello F, Messina M, Zaffe D. Biological width establishment around dental implants is influenced by abutment height irrespective of vertical mucosal thickness: A cluster randomized controlled trial. Clin Oral Implants Res. 2019 Jul;30(7):649-659. doi: 10.1111/clr.13450. Epub 2019 May 12.
- Background: PubMed 25678247Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11.
- 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.
Claudio Stacchi, Dr study director
Piezoelectric Surgery Academy
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 insertion in people with Alveolar Bone Loss and Dental Implant Failure Nos, run by International Piezosurgery Academy 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 9 inclusion and 10 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 10 Aug 2022. 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?
marginal bone loss (time frame: at implant insertion). The study lists 6 primary outcomes in all. 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 NCT05494476, 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 10 Aug 2022.