Skip to main content
OpenTrials
Completed

NCT Number: NCT05944419

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Resorption Bone Diseases Musculoskeletal Diseases Soft Tissue Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Immediate implant surgery

Device

Placement of immediate implant and immediate provisionalization after tooth extraction

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Insertion torque (IT):

    Time frame: day 1

    the insertion torque of the implant was measured on the day of the sur-gery with the implant motor.

  2. ISQ (implant stability quotient):

    Time frame: day 1

    the ISQ was measured at implant placement using the Osstell device, which involves resonance frequency analysis (RFA) for measuring the fre-quency of vibration.

  3. Probing pocket depth (PPD):

    Time frame: 4 months

    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.

  4. Probing pocket depth (PPD):

    Time frame: 1 year

    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.

  5. Probing pocket depth (PPD):

    Time frame: 3 year

    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.

  6. Bleeding on probing (BOP):

    Time frame: 4 months

    bleeding on probing was registered at each PPD site, whether there was bleeding or not.

  7. Bleeding on probing (BOP):

    Time frame: 1 year

    bleeding on probing was registered at each PPD site, whether there was bleeding or not.

  8. Bleeding on probing (BOP):

    Time frame: 3 year

    bleeding on probing was registered at each PPD site, whether there was bleeding or not.

  9. Crestal width (CW)

    Time frame: 4 months

    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.

  10. Crestal width (CW)

    Time frame: 1 year

    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.

  11. Crestal width (CW)

    Time frame: 3 year

    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.

  12. Pink esthetic score (PES):

    Time frame: 4 months

    this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.

  13. Pink esthetic score (PES):

    Time frame: 1 year

    this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.

  14. Pink esthetic score (PES):

    Time frame: 3 year

    this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2023
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.