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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04160689
Other study ID # 002
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 1, 2018
Est. completion date November 1, 2019

Study information

Verified date November 2019
Source University of Milan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

Biological:
implantology
placing of implant

Locations

Country Name City State
Italy University of Insubria Varese

Sponsors (1)

Lead Sponsor Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. after 12 months
Primary 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. 12 months
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