Bone LossNCT07156110
Prosthetic Modality and MBL
A study testing Traditional prosthetic procedure and one abutment-one time in people with Bone Loss, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site in Italy.
Trial summary
The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year. Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Traditional prosthetic procedure and one abutment-one time
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Lack of primary stability less than 35 Ncm.
- Need for augmentation procedures during implant surgery.
- Inability to place the implant according to the prosthetic requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luigi Canullo contact
Italy1 site, 1 recruiting
- Recruiting
Studi Odontoiatrici Luigi Canullo
Roma, RM, 00199
Luigi Canullo, Professor, 3476201976, luigi.canullo@gmail.com
About this study
Official title: The Effect of Prosthetic Modality on Bone Level Changes During One-Year Follow-Up
The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year.
Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Once the implant is inserted, patients will be divided into three groups according to the time if their inclusion in the study.
Read more
Study groups (20 patients per group):
- Group 1: Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 2: Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 3: Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months.
Consecutive inclusion of patients - 1st- group 1, 2nd - group 2, 3rd - group 3 and vice versa.
Primary outcome variable: bone level changes 12 months post-loading
Read the detailed description
Actually, the histologic composition of the soft tissue around the prosthetic district was Indirectly clarified firstly in animal studies focused on biologic width re- establishment, now renamed supracrestal tissue attachment, which described the epithelial and connective components and the key role in the implant longitudinal maintenance they have (1). In fact, it was shown that the soft tissue morphogenesis in humans may occur in 8-12 weeks (2) This histologic structure is represented by a dense connective tissue with few fibroblasts and edondotelial cells isolated by a junctional epithelium indirectly connected to the abutment in the most coronal portion by a thin layer of proteoglycans and psudopodia (3).
Traditionally the Interaction between living cells and a biocompatible foreign material is mediated by some biological factors and could be associated with a mathematical equation Apparently, this is based on few variables generically represented by soft tissue patterns and biomaterial features (4). In fact, according to the basic science, the host tissue (intended both histologically and epigenetically), the biocompatible foreign material and the antagonist.
The tissue variable should be intended not only as its clinical appearance (thin vs thick), but overall as its INDIVIDUAL regenerative and inflammatory capability (which of course involves also the histologic aspect) (5) Changing our prospecting and focusing on the prosthetic variable, this should be intended not only as it is in its macro/micro and nano structure, but also as it is used in the prosthetic work flow In fact, the proximity of the prosthetic components to the connective tissues (mostly evident in case platform switching configuration) could allow the clinician during the healing period to actively influence soft tissue morphogenesis In fact, 2 weeks after reopening, traditional prosthetic work flow provides for healing abutment disconnection and impression taking (just at the peak of the first phases of wound healing) and two weeks there after new disconnections are required for try ins and definitive prosthetic delivery, just when the maturation healing phase peak occurs(6-7).
These continuous dis-reconnections may lead to soft tissue healing disruption with a long junctional epithelium till the IAJ.
Not to mention the fact that continuous disconnections create a link for the contamination of the connection and the exposure of soft tissues to abutment not always contaminated The only approach able to prevent this "physiological reaction" and allow a complete healing is to adopt a protocol aimed, after an intraoperative impression, to definitively screw the final abutment at the time of second surgery and allow soft tissue to heal undisturbed (so called "one-abutment/one-time) (8) Another factor affecting soft tissue/abutment interaction is the abutment macro design A recent systematic review our group recently produced, suggested that narrower abutments fail to show any difference in terms of soft tissue health (and this is reasonable) and esthetics (9).
On the other hand, the metanalysis highlighted significant differences in terms of MBL in favor of narrower abutments just because this configuration allows for more room for soft tissues supracrestal attachment, probably changing their fiber arrangement from parallel to the long axis to ring-shaped circular with a stronger connective seal Another factor related to the "abutment variable" that dramatically may affect soft tissue/abutment interaction, and therefore interacting with the underlaid bone, is its micro design.
In fact, the importance of the material should be shifted from the bulk to the external surface and its biochemophysical and topographic properties, including cleanliness.
In fact, decontamination of the abutment surface is a prerequisite for cell. Aim The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year.
Materials and Methods Study design The study was designed as a prospective, controlled clinical trial with a parallel design. Approval from the Ethics Committee will be obtained before the study commences. Selected patients were informed about the purpose of the study, and if they agreed to participate, they were recruited to participate in the clinical trial once they had signed the informed consent form.
Subject population Subjects in need of an implant-supported restoration will be screened for the following study criteria Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Once the implant is inserted, patients will be divided into three groups according to the time if their inclusion in the study.
Study groups (20 patients per group):
- Group 1: Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 2: Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 3: Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months.
Consecutive inclusion of patients - 1st- group 1, 2nd - group 2, 3rd - group 3 and vice versa.
Information to collect:
Inclusion day: Demographic data, medical condition Day of surgery: implant site, insertion torque, parallel X-ray. Suture removal - adverse effects. 3 months (impression) - parallel X-ray. Adverse effects. Loading day - parallel X-ray. Adverse effects. 6 months post-loading - parallel X-ray. Adverse effects. 12 months post-loading - parallel X-ray. Adverse effects, pocket depth, BOP.
Clinical photos and videos will be appreciated for future presentations.
Primary outcome variable: bone level changes 12 months post-loading Surgical and prosthetic protocol According to the manufacturer's instructions, using the Lance surgical kit, with tools for Conical connection and internal hex implants (fig 1 and 2).
Prosthetic parts will be inserted according to the manufacturer's instructions using the specific tools and a torque-controlled rachet.
- Conditions
- Bone Loss
- Being tested
- Traditional prosthetic procedure, one abutment-one time
- Keywords
- Marginal bone level changes, prosthetic modalities, soft tissue adaptation
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional prosthetic procedureProcedure or surgery
Three months later, after an impression, haling abutment will be removed and a screw-retained restoration will be seated using a Ti-Base abutment.
one abutment-one timeProcedure or surgery
Three months later, after an impression, a screw-retained restoration will be seated directly on the connect healing
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. Receives: Procedure: Traditional prosthetic procedure |
| Arm 2 | Experimental | Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. Receives: Procedure: Traditional prosthetic procedure |
| Arm 3 | Experimental | Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months. Receives: Procedure: one abutment-one time |
What is being measured
The primary outcome is the main question the study is designed to answer.
MBL
magical bone level changes will be measured through X-rays
Measured: one year post surgery
Secondary outcomes (3)
peri-implant soft tissue variables
BoP
Measured: one year post surgery
peri-implant soft tissue variables
Pi
Measured: one year post surgery
peri-implant soft tissue variables
PD
Measured: one year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Sponsor type
- University, hospital or other
- Collaborators
- Alessio Triestino
- Responsible party
- Principal investigator, Luigi Canullo, Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Investigators
- luigi Canullo, prof, Principal investigator, Studi Odontoiatrici Canullo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156110
- Sponsor's protocol ID
- L1
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymized data will be shared if required
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prosthetic Modality on Bone Level Changes During One-Year Follow-Up
- ClinicalTrials.gov ID
- NCT07156110
- Acronym / sponsor ID
- L1
- Conditions
- Bone Loss
- Keywords
- Marginal bone level changes, prosthetic modalities, soft tissue adaptation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. CanulloUniversity, hospital or other
- Collaborators
- Alessio Triestino
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 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.
The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year.
Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Once the implant is inserted, patients will be divided into three groups according to the time if their inclusion in the study.
Study groups (20 patients per group):
- Group 1: Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 2: Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 3: Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months.
Consecutive inclusion of patients - 1st- group 1, 2nd - group 2, 3rd - group 3 and vice versa.
Primary outcome variable: bone level changes 12 months post-loading
Detailed description
Actually, the histologic composition of the soft tissue around the prosthetic district was Indirectly clarified firstly in animal studies focused on biologic width re- establishment, now renamed supracrestal tissue attachment, which described the epithelial and connective components and the key role in the implant longitudinal maintenance they have (1). In fact, it was shown that the soft tissue morphogenesis in humans may occur in 8-12 weeks (2) This histologic structure is represented by a dense connective tissue with few fibroblasts and edondotelial cells isolated by a junctional epithelium indirectly connected to the abutment in the most coronal portion by a thin layer of proteoglycans and psudopodia (3).
Traditionally the Interaction between living cells and a biocompatible foreign material is mediated by some biological factors and could be associated with a mathematical equation Apparently, this is based on few variables generically represented by soft tissue patterns and biomaterial features (4). In fact, according to the basic science, the host tissue (intended both histologically and epigenetically), the biocompatible foreign material and the antagonist.
The tissue variable should be intended not only as its clinical appearance (thin vs thick), but overall as its INDIVIDUAL regenerative and inflammatory capability (which of course involves also the histologic aspect) (5) Changing our prospecting and focusing on the prosthetic variable, this should be intended not only as it is in its macro/micro and nano structure, but also as it is used in the prosthetic work flow In fact, the proximity of the prosthetic components to the connective tissues (mostly evident in case platform switching configuration) could allow the clinician during the healing period to actively influence soft tissue morphogenesis In fact, 2 weeks after reopening, traditional prosthetic work flow provides for healing abutment disconnection and impression taking (just at the peak of the first phases of wound healing) and two weeks there after new disconnections are required for try ins and definitive prosthetic delivery, just when the maturation healing phase peak occurs(6-7).
These continuous dis-reconnections may lead to soft tissue healing disruption with a long junctional epithelium till the IAJ.
Not to mention the fact that continuous disconnections create a link for the contamination of the connection and the exposure of soft tissues to abutment not always contaminated The only approach able to prevent this "physiological reaction" and allow a complete healing is to adopt a protocol aimed, after an intraoperative impression, to definitively screw the final abutment at the time of second surgery and allow soft tissue to heal undisturbed (so called "one-abutment/one-time) (8) Another factor affecting soft tissue/abutment interaction is the abutment macro design A recent systematic review our group recently produced, suggested that narrower abutments fail to show any difference in terms of soft tissue health (and this is reasonable) and esthetics (9).
On the other hand, the metanalysis highlighted significant differences in terms of MBL in favor of narrower abutments just because this configuration allows for more room for soft tissues supracrestal attachment, probably changing their fiber arrangement from parallel to the long axis to ring-shaped circular with a stronger connective seal Another factor related to the "abutment variable" that dramatically may affect soft tissue/abutment interaction, and therefore interacting with the underlaid bone, is its micro design.
In fact, the importance of the material should be shifted from the bulk to the external surface and its biochemophysical and topographic properties, including cleanliness.
In fact, decontamination of the abutment surface is a prerequisite for cell. Aim The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year.
Materials and Methods Study design The study was designed as a prospective, controlled clinical trial with a parallel design. Approval from the Ethics Committee will be obtained before the study commences. Selected patients were informed about the purpose of the study, and if they agreed to participate, they were recruited to participate in the clinical trial once they had signed the informed consent form.
Subject population Subjects in need of an implant-supported restoration will be screened for the following study criteria Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Once the implant is inserted, patients will be divided into three groups according to the time if their inclusion in the study.
Study groups (20 patients per group):
- Group 1: Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 2: Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment.
- Group 3: Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months.
Consecutive inclusion of patients - 1st- group 1, 2nd - group 2, 3rd - group 3 and vice versa.
Information to collect:
Inclusion day: Demographic data, medical condition Day of surgery: implant site, insertion torque, parallel X-ray. Suture removal - adverse effects. 3 months (impression) - parallel X-ray. Adverse effects. Loading day - parallel X-ray. Adverse effects. 6 months post-loading - parallel X-ray. Adverse effects. 12 months post-loading - parallel X-ray. Adverse effects, pocket depth, BOP.
Clinical photos and videos will be appreciated for future presentations.
Primary outcome variable: bone level changes 12 months post-loading Surgical and prosthetic protocol According to the manufacturer's instructions, using the Lance surgical kit, with tools for Conical connection and internal hex implants (fig 1 and 2).
Prosthetic parts will be inserted according to the manufacturer's instructions using the specific tools and a torque-controlled rachet.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Procedure: Traditional prosthetic procedurePlacing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. |
| Arm 2 | Experimental | Procedure: Traditional prosthetic procedurePlacing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. |
| Arm 3 | Experimental | Procedure: one abutment-one timePlacing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Lack of primary stability less than 35 Ncm.
- Need for augmentation procedures during implant surgery.
- Inability to place the implant according to the prosthetic requirements.
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 |
|---|---|---|
| Traditional prosthetic procedureThree months later, after an impression, haling abutment will be removed and a screw-retained restoration will be seated using a Ti-Base abutment. | Procedure or surgery | Arm 1, Arm 2 |
| one abutment-one timeThree months later, after an impression, a screw-retained restoration will be seated directly on the connect healing | Procedure or surgery | Arm 3 |
Primary outcome
MBL
Time frame: one year post surgery
magical bone level changes will be measured through X-rays
3 secondary outcomes
peri-implant soft tissue variables
Time frame: one year post surgery
peri-implant soft tissue variables
Time frame: one year post surgery
peri-implant soft tissue variables
Time frame: one year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. anonymized data will be shared if required
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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.
Luigi Canullo contact
luigi Canullo, prof principal investigator
Studi Odontoiatrici Canullo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional prosthetic procedure and one abutment-one time in people with Bone Loss, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo 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 0 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: looking for participants now, as of the sponsor's last update on 4 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Canullo, prof (3476201976 ext. +39, luigi.canullo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MBL (time frame: one year post surgery). 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 4 Sep 2025.