Bone ResorptionNCT05944419

Influence of Neck Design on Peri-implant Hard and Soft Tissues

A study testing Immediate implant surgery in people with Bone Resorption and Soft Tissue Bleeding, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to test two different implant neck designs in 36 patients. The main question[s] it aims to answer are: do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bone Resorption, Soft Tissue Bleeding
What is being tested?: Immediate implant surgery
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteSpain
Study dates: 15 Jun 2016to 15 Sep 2023
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

healthy non-smokers or light smokers (< 10 cigarettes/day)
adults (> 18 years of age),
need for single tooth extraction of a maxillary incisor, canine or premolar
adequate oral hygiene
ability to follow instructions and attend the required appointments
presence of a length of at least 3 mm of buccal bone measuring ≥ 0.5 mm in thickness, apical to the extraction socket
stable and intact socket walls

Who cannot join

patients with acute infections in the area of interest
individuals with large occlusal discrepancies and/or occlusal overload para-functions
smokers of more than 10 cigarettes/day
patients with any medical condition or medication contraindicating dental implant treatment

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195

Other trials in Spain

About this study

The goal of this clinical trial is to test two different implant neck designs in 36 patients. The main question[s] it aims to answer are:

do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at one year?
do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at three years?

Participants that present an unrepairable tooth on the anterior upper maxilla will be asked to take a CBCT scan in order to verify the presence of the buccal bone. Once this is verified the patients will enter in the study and the day of the surgery they will be assigned to either control or test group.

Control group: C1 round-neck implant
Test groups: V3 triangular-implant neck

Researchers will compare test and control groups to see if they have the same effects on hard and soft tissues at 4 months, 1 year and 3 years.

Read the detailed description

Immediate implant placement is considered to be a technique-sensitive protocol with a variety of potential risks. The interface area between the neck of the implant and the abutment is critical; it can affect the treatment outcome, particularly mar-ginal bone loss (MBL) and soft tissue behavior. Traditionally, the implant neck is circu-lar in shape; however, a new triangular neck design has recently been introduced on the market, though advanced indications of this innovative design are still lacking.

The objective of this randomized clinical trial was to compare the clinical and radiographic outcomes obtained after immediate placement of implants and temporization of two different neck geometries: a traditional round neck (RN) and an innovative neck with a triangular shape (TN).

Conditions: Bone Resorption, Soft Tissue Bleeding
Being tested: Immediate implant surgery
Keywords: dental implants, implant neck design, immediate implants, immediate provisionalization, buccal bone thickness
Medical subject headings: Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate implant surgeryDevice
Placement of immediate implant and immediate provisionalization after tooth extraction

Study groups in NCT05944419
Study group	Role	What they receive
V3 Implant MIS Iberica	Active comparator	Implant with triangular neck macro design Receives: Device: Immediate implant surgery
C1 Implant MIS Iberica	Active comparator	Implant with circular neck macro design Receives: Device: Immediate implant surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Buccal bone width (BBW)
buccal bone width was measured by CBCT (iCAT®, Imaging Science International, LLC, Hatfield, PA, USA) at four points: at the implant neck, and at 1 mm, 2 mm and 3 mm above the implant neck.
Measured: 4 months
Marginal bone loss (MBL)
marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Measured: 4 months
Marginal bone loss (MBL)
marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Measured: 1 years
Marginal bone loss (MBL)
marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Measured: 3 years
Soft tissue thickness (STT)
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Measured: 4 months
Soft tissue thickness (STT)
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Measured: 1 years
Soft tissue thickness (STT)
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Measured: 3 years

Secondary outcomes (14)

Insertion torque (IT):
the insertion torque of the implant was measured on the day of the sur-gery with the implant motor.
Measured: day 1
ISQ (implant stability quotient):
the ISQ was measured at implant placement using the Osstell device, which involves resonance frequency analysis (RFA) for measuring the fre-quency of vibration.
Measured: day 1
Probing pocket depth (PPD):
probing pocket depth was measured with a Marquis Color code dental probe at 6 sites covering 360ª of the tooth: three on the buccal site and three on the palatal site of each tooth.
Measured: 4 months
Probing pocket depth (PPD):
probing pocket depth was measured with a Marquis Color code dental probe at 6 sites covering 360ª of the tooth: three on the buccal site and three on the palatal site of each tooth.
Measured: 1 year
Probing pocket depth (PPD):
probing pocket depth was measured with a Marquis Color code dental probe at 6 sites covering 360ª of the tooth: three on the buccal site and three on the palatal site of each tooth.
Measured: 3 year
Bleeding on probing (BOP):
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Measured: 4 months
Bleeding on probing (BOP):
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Measured: 1 year
Bleeding on probing (BOP):
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Measured: 3 year
Crestal width (CW)
at 3 mm and 5 mm from the gingival margin: a gauge compass was used to measure the whole width of the crestal volume, from palatal to ves-tibular wall.
Measured: 4 months
Crestal width (CW)
at 3 mm and 5 mm from the gingival margin: a gauge compass was used to measure the whole width of the crestal volume, from palatal to ves-tibular wall.
Measured: 1 year
Crestal width (CW)
at 3 mm and 5 mm from the gingival margin: a gauge compass was used to measure the whole width of the crestal volume, from palatal to ves-tibular wall.
Measured: 3 year
Pink esthetic score (PES):
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
Measured: 4 months
Pink esthetic score (PES):
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
Measured: 1 year
Pink esthetic score (PES):
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
Measured: 3 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201615 Sep 2023

First posted13 Jul 2023
Study start15 Jun 2016
Primary completion15 Sep 2023
Study completion15 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bone ResorptionStudies 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
Model description: Randomized Controlled Clinical Trial
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05944419
Sponsor's protocol ID: CIR-ECL-2016-05
Status last verified: Dec 2023
First submitted: 7 Jun 2023
Last updated: 14 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Porta-Ferrer C, Elnayef-Elsakan B, Del Amo FS, Caballe-Serrano J, Satorres-Nieto M, Hernandez-Alfaro F. Influence of Neck Design on Peri-Implant Hard and Soft Tissues: A 12-Month Randomized Clinical Trial of Immediately Placed Implants. Clin Oral Implants Res. 2026 Mar;37(3):287-302. doi: 10.1111/clr.70068. Epub 2025 Nov 23.
PubMed 41275475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bone Resorption trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Influence of Neck Design on Peri-implant Hard and Soft Tissues
ClinicalTrials.gov ID: NCT05944419
Acronym / sponsor ID: CIR-ECL-2016-05
Conditions: Bone Resorption, Soft Tissue Bleeding
Keywords: dental implants, implant neck design, immediate implants, immediate provisionalization, buccal bone thickness
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Universitat Internacional de CatalunyaUniversity, hospital or other
Study start: 15 Jun 2016 (actual)
Primary completion: 15 Sep 2023 (actual)
Study completion: 15 Sep 2023 (actual)
First posted: 13 Jul 2023 (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 goal of this clinical trial is to test two different implant neck designs in 36 patients. The main question[s] it aims to answer are:

do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at one year?
do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at three years?

Control group: C1 round-neck implant
Test groups: V3 triangular-implant neck

Researchers will compare test and control groups to see if they have the same effects on hard and soft tissues at 4 months, 1 year and 3 years.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized Controlled Clinical Trial

Arm	Type	Receives
V3 Implant MIS Iberica	Active comparator	Device: Immediate implant surgeryImplant with triangular neck macro design
C1 Implant MIS Iberica	Active comparator	Device: Immediate implant surgeryImplant with circular neck macro design

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

healthy non-smokers or light smokers (< 10 cigarettes/day)
adults (> 18 years of age),
need for single tooth extraction of a maxillary incisor, canine or premolar
adequate oral hygiene
ability to follow instructions and attend the required appointments

Key exclusion criteria (4 listed)

patients with acute infections in the area of interest
individuals with large occlusal discrepancies and/or occlusal overload para-functions
smokers of more than 10 cigarettes/day
patients with any medical condition or medication contraindicating dental implant treatment

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
Immediate implant surgeryPlacement of immediate implant and immediate provisionalization after tooth extraction	Device	C1 Implant MIS Iberica, V3 Implant MIS Iberica

Primary outcome

Buccal bone width (BBW)
Time frame: 4 months
buccal bone width was measured by CBCT (iCAT®, Imaging Science International, LLC, Hatfield, PA, USA) at four points: at the implant neck, and at 1 mm, 2 mm and 3 mm above the implant neck.
Marginal bone loss (MBL)
Time frame: 4 months
marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Marginal bone loss (MBL)
Time frame: 1 years
marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Marginal bone loss (MBL)
Time frame: 3 years
marginal bone loss was measured on mesial and distal aspects of the implant using intraoral standardized periapical radiographs with the parallel technique. Measurements were performed using K-Pacs Work-station (Image Information Systems, Ltd.). The distance from the implant shoulder to the first bone-implant contact was measured at the mesial and distal sites.
Soft tissue thickness (STT)
Time frame: 4 months
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Soft tissue thickness (STT)
Time frame: 1 years
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Soft tissue thickness (STT)
Time frame: 3 years
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.

14 secondary outcomes

Insertion torque (IT):
Time frame: day 1
ISQ (implant stability quotient):
Time frame: day 1
Probing pocket depth (PPD):
Time frame: 4 months
Probing pocket depth (PPD):
Time frame: 1 year
Probing pocket depth (PPD):
Time frame: 3 year
Bleeding on probing (BOP):
Time frame: 4 months
Bleeding on probing (BOP):
Time frame: 1 year
Bleeding on probing (BOP):
Time frame: 3 year
Crestal width (CW)
Time frame: 4 months
Crestal width (CW)
Time frame: 1 year
Crestal width (CW)
Time frame: 3 year
Pink esthetic score (PES):
Time frame: 4 months
Pink esthetic score (PES):
Time frame: 1 year
Pink esthetic score (PES):
Time frame: 3 year

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 14 Dec 2023.
Derived from this study: PubMed 41275475Porta-Ferrer C, Elnayef-Elsakan B, Del Amo FS, Caballe-Serrano J, Satorres-Nieto M, Hernandez-Alfaro F. Influence of Neck Design on Peri-Implant Hard and Soft Tissues: A 12-Month Randomized Clinical Trial of Immediately Placed Implants. Clin Oral Implants Res. 2026 Mar;37(3):287-302. doi: 10.1111/clr.70068. Epub 2025 Nov 23.

Related trials for Bone Resorption

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Active, not recruiting
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos

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.

CRISTINA PORTA FERRER principal investigator

Universitat Internacional de Catalunya

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Immediate implant surgery in people with Bone Resorption and Soft Tissue Bleeding, run by Universitat Internacional de Catalunya at 1 site in Spain.

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 7 inclusion and 4 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 14 Dec 2023. 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 Spain. 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?

Buccal bone width (BBW) (time frame: 4 months). The study lists 7 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 NCT05944419, which also lists 1 linked publication.

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 14 Dec 2023.