Influence of the Implant Connection on Facial Tissues Maturation

November 12, 2019 updated by: Marco Farronato, University of Milan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Varese, Italy
        • University of Insubria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
Anyridge (Mega'Gen, Korea) 5° conical internal hexed connection
Biological: implantology
placing of implant
ACTIVE_COMPARATOR: Group 2
Core (Bioimplant, Italy) 35° conical internal hexed connection (screw-vent style)
Biological: implantology
placing of implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height of the peri-implant mucosa (MH)
Time Frame: after 12 months
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.
after 12 months
The width (MT) of the peri-implant mucosa
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

November 9, 2019

First Submitted That Met QC Criteria

November 9, 2019

First Posted (ACTUAL)

November 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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