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

NCT05944419 | Completed

• 1 other identifier: CIR-ECL-2016-05
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Bone Resorption; Soft Tissue Bleeding

Keywords

dental implants; implant neck design; immediate implants; immediate provisionalization; buccal bone thickness

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  3 years

Secondary Outcomes (14)

• Insertion torque (IT):

  day 1

• ISQ (implant stability quotient):

  day 1

• Probing pocket depth (PPD):

  4 months

• Probing pocket depth (PPD):

  1 year

• Probing pocket depth (PPD):

  3 year

Study Arms (2)

V3 Implant MIS Iberica

ACTIVE COMPARATOR

Implant with triangular neck macro design

Device: Immediate implant surgery

C1 Implant MIS Iberica

ACTIVE COMPARATOR

Implant with circular neck macro design

Device: Immediate implant surgery

Interventions

Immediate implant surgery DEVICE

Placement of immediate implant and immediate provisionalization after tooth extraction

C1 Implant MIS Iberica; V3 Implant MIS Iberica

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Related Publications (1)

• 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. 2025 Nov 23. doi: 10.1111/clr.70068. Online ahead of print.

  PMID: 41275475 DERIVED

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• CRISTINA PORTA FERRER

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, MSc, PhD

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 13, 2023
• Study Start: June 15, 2016
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

ES (1)