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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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

luigi.canullo@gmail.com

Italy1 site, 1 recruiting
  • Studi Odontoiatrici Luigi Canullo

    Roma, RM, 00199

    Luigi Canullo, Professor, 3476201976, luigi.canullo@gmail.com

    Recruiting

Other trials in Italy

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):

  1. 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.
  2. 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.
  3. 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):

  1. 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.
  2. 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.
  3. 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 groups in NCT07156110
Study groupRoleWhat they receive
Arm 1Active comparatorPlacing 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 2ExperimentalPlacing 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 3ExperimentalPlacing 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.

  1. MBL

    magical bone level changes will be measured through X-rays

    Measured: one year post surgery

Secondary outcomes (3)
  1. peri-implant soft tissue variables

    BoP

    Measured: one year post surgery

  2. peri-implant soft tissue variables

    Pi

    Measured: one year post surgery

  3. 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.

  1. First posted4 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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