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

Primary Purpose

Bone Resorption, Soft Tissue Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Immediate implant surgery
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption focused on measuring dental implants, implant neck design, immediate implants, immediate provisionalization, buccal bone thickness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

V3 Implant MIS Iberica

C1 Implant MIS Iberica

Arm Description

Implant with triangular neck macro design

Implant with circular neck macro design

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Insertion torque (IT):
the insertion torque of the implant was measured on the day of the sur-gery with the implant motor.
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.
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.
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.
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.
Bleeding on probing (BOP):
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Bleeding on probing (BOP):
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Bleeding on probing (BOP):
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 7, 2023
Last Updated
July 5, 2023
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05944419
Brief Title
Influence of Neck Design on Peri-implant Hard and Soft Tissues
Official Title
Influence of Neck Design on Peri-implant Hard and Soft Tissues
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption, Soft Tissue Bleeding
Keywords
dental implants, implant neck design, immediate implants, immediate provisionalization, buccal bone thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Clinical Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V3 Implant MIS Iberica
Arm Type
Active Comparator
Arm Description
Implant with triangular neck macro design
Arm Title
C1 Implant MIS Iberica
Arm Type
Active Comparator
Arm Description
Implant with circular neck macro design
Intervention Type
Device
Intervention Name(s)
Immediate implant surgery
Intervention Description
Placement of immediate implant and immediate provisionalization after tooth extraction
Primary Outcome Measure Information:
Title
Buccal bone width (BBW)
Description
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.
Time Frame
4 months
Title
Marginal bone loss (MBL)
Description
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.
Time Frame
4 months
Title
Marginal bone loss (MBL)
Description
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.
Time Frame
1 years
Title
Marginal bone loss (MBL)
Description
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.
Time Frame
3 years
Title
Soft tissue thickness (STT)
Description
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Time Frame
4 months
Title
Soft tissue thickness (STT)
Description
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Time Frame
1 years
Title
Soft tissue thickness (STT)
Description
the thickness of the buccal soft tissue at 3 mm and 5 mm from the gingi-val margin was measured using an endodontic file.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Insertion torque (IT):
Description
the insertion torque of the implant was measured on the day of the sur-gery with the implant motor.
Time Frame
day 1
Title
ISQ (implant stability quotient):
Description
the ISQ was measured at implant placement using the Osstell device, which involves resonance frequency analysis (RFA) for measuring the fre-quency of vibration.
Time Frame
day 1
Title
Probing pocket depth (PPD):
Description
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.
Time Frame
4 months
Title
Probing pocket depth (PPD):
Description
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.
Time Frame
1 year
Title
Probing pocket depth (PPD):
Description
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.
Time Frame
3 year
Title
Bleeding on probing (BOP):
Description
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Time Frame
4 months
Title
Bleeding on probing (BOP):
Description
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Time Frame
1 year
Title
Bleeding on probing (BOP):
Description
bleeding on probing was registered at each PPD site, whether there was bleeding or not.
Time Frame
3 year
Title
Crestal width (CW)
Description
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.
Time Frame
4 months
Title
Crestal width (CW)
Description
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.
Time Frame
1 year
Title
Crestal width (CW)
Description
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.
Time Frame
3 year
Title
Pink esthetic score (PES):
Description
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
Time Frame
4 months
Title
Pink esthetic score (PES):
Description
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
Time Frame
1 year
Title
Pink esthetic score (PES):
Description
this score was measured based on the Furhauser table. Maximum: 14 points / Minimum: 0 points. Higher scores mean a better outcome.
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CRISTINA PORTA FERRER, MSC
Phone
+34626723012
Email
cristinapf@uic.es
First Name & Middle Initial & Last Name or Official Title & Degree
JAVIER GAMON VIDAL
Phone
+34627321249
Email
jgamon@uic.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CRISTINA PORTA FERRER
Organizational Affiliation
Universitat Internacional de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CRISTINA PORTA FERRER
Phone
+34626723012
Email
cristinapf@uic.es
First Name & Middle Initial & Last Name & Degree
JAVIER GAMON VIDAL
Phone
+34627321249
Email
jgamon@uic.es

12. IPD Sharing Statement

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

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