Dental Implant PlacementNCT05552768
Supracrestal Tissue Attachment Dimensions & Peri-implant Health
A study testing Bone level-driven placement and Biological width-driven placement guidelines in people with Dental Implant Placement, run by MIS Implant Technologies, Ltd at 1 site in Israel.
Trial summary
Decision making in regards to the 3D implant positioning in partially edentulous sites is a complex process particularly when there are adjacent teeth present. Presently, the prevailing paradigm of implant placement guidelines is bone-driven. It calls to seat the implant neck in a crestal position. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Placement
- What is being tested?
- Bone level-driven placement and Biological width-driven placement guidelines
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Jun 2022to 1 Jan 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults 21-75-year old;
- ASA 1-3 with no medical contraindication for implant surgery;
- Edentulous site(s) in need of implant-supported fixed restoration of one or up to three units supported by 2 implants;
- availability of native bone of at least 6 mm in width to accommodate standard Ø 3.75 and 4.2 mm implant without any need for bone augmentation;
- bone height to accommodate 10 mm long implants accounting for up to 2 mm of subcrestal placement in the mandible and the maxilla;
- adequate oral hygiene and stable periodontal status with bleeding on probing (BOP) < 20% and plaque index (PI) < 30%;
- keratinized gingiva ≥ 4 mm;
- willing to sign an informed consent and ability and willingness to comply with all study visits.
Who cannot join
- moderate or heavy smoking (≥10 cigarettes per day);
- systemic diseases preventing implant placement;
- uncontrolled diabetes (HbA1c ≥ 8%), osteoporosis as confirmed by z/t score, or other conditions or medications affecting bone healing;
- poor oral hygiene;
- alcoholism and recreational drug addiction;
- uncontrolled periodontitis;
Show all 13Show fewer
- pregnant or lactating women;
- local exclusion criteria
- Immediate implant placement;
- socket preservation with a bone substitute biomaterial less than 6 months prior, or 9 months prior for xenografts;
- vertical (Seibert class II / III defect exceeding 3 mm that would compromise ideal apicocoronal placement);
- prior ridge augmentation / GBR procedure
- implant primary stability not enabling torquing the CONNECT abutment at 30 Ncm without rotation;
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Mis Implants Technologies Ltd.
Misgav Regional Council, 2015600
Michal Malka, +972547257128, michal.malka@dentsplysirona.com
Serge Szmukler, Dr, +972537085454, serge.szmukler@dentsplysirona.com
About this study
Official title: Effects of Supracrestal Tissue Attachment Dimensions on Peri-implant Health: A RCT
Decision making in regards to the 3D implant positioning in partially edentulous sites is a complex process particularly when there are adjacent teeth present. Presently, the prevailing paradigm of implant placement guidelines is bone-driven. It calls to seat the implant neck in a crestal position. Clinical studies have demonstrated that implants placed in sites with thin soft tissues are suffering more crestal bone loss than sites with thick gingiva. Consequently, it has been proposed either to place these implants in a subcrestal position or to thicken locally the soft tissues. A recommendation of how much subcrestally the implants should be inserted in these sites is still lacking but clinicians empirically implement a deeper insertion of 1.5-2 mm under the crest. There is some indication that subcrestal placement may lead to bone remodeling above the implant neck and limited bone loss beyond the neck, but clinical trials of bone level implants have not been performed to answer this definitively.
Evolving data on the dimensions of the supracrestal tissue attachment zone (aka biological width, BW) around implants suggest that a distance of 4 mm is reserved to accommodate for junctional epithelial and connective tissue attachment zones as well as a healthy peri-implant sulcus. The objective of this study will be to determine if implants placed according to the soft tissue-driving implant placement paradigm, i.e. 4 mm below the tissue margin and associated with a deeper mucosal tunnel will have less bone loss but a more compromised peri-implant health as compared to implants placed at the bone crest level following the bone-driven implant placement paradigm with more bone loss but a shallower mucosal tunnel.It is hypothesized that using the CONNECT as a dedicated immediate tissue-level abutment system which enables avoiding alteration of the peri-implant gingival seal, both groups, the one with a deeper mucosal tunnel and the one with a shallower one, will perform identical in terms of peri-implant health and tissue maintenance outcomes. This would then justify the safe placement of implants in a biologically appropriate manner using biological width-driven placement guidelines.
Read more
To test this hypothesis, two groups of 30 patients each will be treated according to either the bone-driven or the soft tissue-driven concepts:
Control group following the bone level-driven placement guidelines (BL Group): Implants will be placed at the bone level, they will receive a 1.5-2 mm long CONNECT abutment.
Test group following the biological width-driven placement guidelines (BW Group): Implants will be placed 4 mm below the mucosal margin using a 3 mm long CONNECT abutment: this means that the implant will be placed sub-crestally in agreement with the corresponding guideline, i.e. at deepest 1 mm subcrestally.
- Conditions
- Dental Implant Placement
- Being tested
- Bone level-driven placement, Biological width-driven placement guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone level-driven placementProcedure or surgery
The objective of this study will be to determine if implants placed according to the soft tissue-driving implant placement paradigm, i.e. 4 mm below the tissue margin will have different clinical performance as compared to the bone level-driven placement paradigm.
Biological width-driven placement guidelinesProcedure or surgery
Biological width-driven placement guidelines
| Study group | Role | What they receive |
|---|---|---|
| Bone level-driven placement (BL Group) | Active comparator | Implants will be placed at the bone level, they will receive a 1.5-2 mm long CONNECT abutment. Receives: Procedure: Bone level-driven placement |
| Biological width-driven placement guidelines (BW Group) | Experimental | Implants will be placed 4 mm below the mucosal margin using a 2-3 mm long CONNECT abutment. Receives: Procedure: Biological width-driven placement guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing depth (PD)
Measured: 12 months post-loading
Secondary outcomes (4)
Change in marginal bone levels (radiographic)
Measured: 12 months post-loading
Change in BOP
Measured: 12 months post-loading
Frequency of peri-implantitis according to the AAP classification criteria
Measured: 12 months post-loading
Number of participants with Implant Success
Measured: 12 months post-loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start20 Jun 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant PlacementStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MIS Implant Technologies, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Serge Szmukler, Dr, Study director, Director of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552768
- Sponsor's protocol ID
- MIS2021-01
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supracrestal Tissue Attachment Dimensions on Peri-implant Health: A RCT
- ClinicalTrials.gov ID
- NCT05552768
- Acronym / sponsor ID
- MIS2021-01
- Conditions
- Dental Implant Placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MIS Implant Technologies, LtdIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Health Science Center at San Antonio
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 23 Sep 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.
Decision making in regards to the 3D implant positioning in partially edentulous sites is a complex process particularly when there are adjacent teeth present. Presently, the prevailing paradigm of implant placement guidelines is bone-driven. It calls to seat the implant neck in a crestal position. Clinical studies have demonstrated that implants placed in sites with thin soft tissues are suffering more crestal bone loss than sites with thick gingiva. Consequently, it has been proposed either to place these implants in a subcrestal position or to thicken locally the soft tissues. A recommendation of how much subcrestally the implants should be inserted in these sites is still lacking but clinicians empirically implement a deeper insertion of 1.5-2 mm under the crest. There is some indication that subcrestal placement may lead to bone remodeling above the implant neck and limited bone loss beyond the neck, but clinical trials of bone level implants have not been performed to answer this definitively.
Evolving data on the dimensions of the supracrestal tissue attachment zone (aka biological width, BW) around implants suggest that a distance of 4 mm is reserved to accommodate for junctional epithelial and connective tissue attachment zones as well as a healthy peri-implant sulcus. The objective of this study will be to determine if implants placed according to the soft tissue-driving implant placement paradigm, i.e. 4 mm below the tissue margin and associated with a deeper mucosal tunnel will have less bone loss but a more compromised peri-implant health as compared to implants placed at the bone crest level following the bone-driven implant placement paradigm with more bone loss but a shallower mucosal tunnel.It is hypothesized that using the CONNECT as a dedicated immediate tissue-level abutment system which enables avoiding alteration of the peri-implant gingival seal, both groups, the one with a deeper mucosal tunnel and the one with a shallower one, will perform identical in terms of peri-implant health and tissue maintenance outcomes. This would then justify the safe placement of implants in a biologically appropriate manner using biological width-driven placement guidelines.
To test this hypothesis, two groups of 30 patients each will be treated according to either the bone-driven or the soft tissue-driven concepts:
Control group following the bone level-driven placement guidelines (BL Group): Implants will be placed at the bone level, they will receive a 1.5-2 mm long CONNECT abutment.
Test group following the biological width-driven placement guidelines (BW Group): Implants will be placed 4 mm below the mucosal margin using a 3 mm long CONNECT abutment: this means that the implant will be placed sub-crestally in agreement with the corresponding guideline, i.e. at deepest 1 mm subcrestally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone level-driven placement (BL Group) | Active comparator | Procedure: Bone level-driven placementImplants will be placed at the bone level, they will receive a 1.5-2 mm long CONNECT abutment. |
| Biological width-driven placement guidelines (BW Group) | Experimental | Procedure: Biological width-driven placement guidelinesImplants will be placed 4 mm below the mucosal margin using a 2-3 mm long CONNECT abutment. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adults 21-75-year old;
- ASA 1-3 with no medical contraindication for implant surgery;
- Edentulous site(s) in need of implant-supported fixed restoration of one or up to three units supported by 2 implants;
- availability of native bone of at least 6 mm in width to accommodate standard Ø 3.75 and 4.2 mm implant without any need for bone augmentation;
- bone height to accommodate 10 mm long implants accounting for up to 2 mm of subcrestal placement in the mandible and the maxilla;
Key exclusion criteria (13 listed)
- moderate or heavy smoking (≥10 cigarettes per day);
- systemic diseases preventing implant placement;
- uncontrolled diabetes (HbA1c ≥ 8%), osteoporosis as confirmed by z/t score, or other conditions or medications affecting bone healing;
- poor oral hygiene;
- alcoholism and recreational drug addiction;
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 |
|---|---|---|
| Bone level-driven placementThe objective of this study will be to determine if implants placed according to the soft tissue-driving implant placement paradigm, i.e. 4 mm below the tissue margin will have different clinical performance as compared to the bone level-driven placement paradigm. | Procedure or surgery | Bone level-driven placement (BL Group) |
| Biological width-driven placement guidelinesBiological width-driven placement guidelines | Procedure or surgery | Biological width-driven placement guidelines (BW Group) |
Primary outcome
Change in probing depth (PD)
Time frame: 12 months post-loading
4 secondary outcomes
Change in marginal bone levels (radiographic)
Time frame: 12 months post-loading
Change in BOP
Time frame: 12 months post-loading
Frequency of peri-implantitis according to the AAP classification criteria
Time frame: 12 months post-loading
Number of participants with Implant Success
Time frame: 12 months post-loading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- 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.
Serge Szmukler, Dr study director
Director of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone level-driven placement and Biological width-driven placement guidelines in people with Dental Implant Placement, run by MIS Implant Technologies, Ltd at 1 site in Israel.
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 8 inclusion and 13 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 23 Sep 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 Israel. 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 Michal Malka (+972547257128, michal.malka@dentsplysirona.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in probing depth (PD) (time frame: 12 months post-loading). 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 23 Sep 2022.