Influence of the Implant Connection on Facial Tissues Maturation

Bone Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160689
• Other study ID #: 002
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Loss
• Implant Tissue Failure
• Periodontal Bone Loss

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