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Influence of the Implant Connection on Facial Tissues Maturation

Primary Purpose

Bone Loss, Periodontal Bone Loss, Implant Tissue Failure

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
implantology
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Missing teeth
  • good oral hygiene
  • good systemic health

Exclusion Criteria:

  • lactation
  • pregnancy
  • heavy smoking (more than 20 cigarettes/day)
  • severe medical conditions that could affect periodontal health and peri-implant tissue response
  • use of drugs correlated to periodontal hypertrophy
  • bone volume that required bone augmentation procedures before implant placement as well as soft tissue graft or any kind of peri-implant tissue engineering

Sites / Locations

  • University of Insubria

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Anyridge (Mega'Gen, Korea) 5° conical internal hexed connection

Core (Bioimplant, Italy) 35° conical internal hexed connection (screw-vent style)

Outcomes

Primary Outcome Measures

height of the peri-implant mucosa (MH)
This measurement (MH) corresponds to the depth of the implant referred to the most coronal point of the buccal mucosa measured according to the main implant axis digitally calculated by 3D software Gom.
The width (MT) of the peri-implant mucosa
was calculated from the vestibular shoulder of the analogue to the external mucosa point perpendicular to the implant major axis digitally calculated by 3D software Gom.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2019
Last Updated
November 12, 2019
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT04160689
Brief Title
Influence of the Implant Connection on Facial Tissues Maturation
Official Title
Influence of the Implant-Abutment Connection on the Ratio Between Height and Thickness of Tissues at the Buccal Implant Zenith: a Perspective Randomised 3d Comparative Analysis on 188 Implants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

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 substitution of a tooth with a fixture often induces undesired morphological changes, resulting in a deterioration of the aesthetic appearance. The purpose of this study is to compare the soft tissue behavior next to two different implant connections: 5° (group 1) and 35° hexed (group 2), conical, internal with switching platform design after 12 months of functional provisionalization

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Periodontal Bone Loss, Implant Tissue Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Anyridge (Mega'Gen, Korea) 5° conical internal hexed connection
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Core (Bioimplant, Italy) 35° conical internal hexed connection (screw-vent style)
Intervention Type
Biological
Intervention Name(s)
implantology
Intervention Description
placing of implant
Primary Outcome Measure Information:
Title
height of the peri-implant mucosa (MH)
Description
This measurement (MH) corresponds to the depth of the implant referred to the most coronal point of the buccal mucosa measured according to the main implant axis digitally calculated by 3D software Gom.
Time Frame
after 12 months
Title
The width (MT) of the peri-implant mucosa
Description
was calculated from the vestibular shoulder of the analogue to the external mucosa point perpendicular to the implant major axis digitally calculated by 3D software Gom.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Missing teeth good oral hygiene good systemic health Exclusion Criteria: lactation pregnancy heavy smoking (more than 20 cigarettes/day) severe medical conditions that could affect periodontal health and peri-implant tissue response use of drugs correlated to periodontal hypertrophy bone volume that required bone augmentation procedures before implant placement as well as soft tissue graft or any kind of peri-implant tissue engineering
Facility Information:
Facility Name
University of Insubria
City
Varese
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32066431
Citation
Farronato D, Pasini PM, Manfredini M, Scognamiglio C, Orsina AA, Farronato M. Influence of the implant-abutment connection on the ratio between height and thickness of tissues at the buccal zenith: a randomized controlled trial on 188 implants placed in 104 patients. BMC Oral Health. 2020 Feb 17;20(1):53. doi: 10.1186/s12903-020-1037-5.
Results Reference
derived

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Influence of the Implant Connection on Facial Tissues Maturation

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