Influence of the Implant Connection on Facial Tissues Maturation

Phase 4

Completed

• Conditions: Bone Loss; Implant Tissue Failure; Periodontal Bone Loss
• Interventions: Biological: implantology

• Registration Number: NCT04160689
• Lead Sponsor: University of Milan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2019-11
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Study First Submitted: 2019-11-09
• Study First Submitted QC: 2019-11-09
• Last Update Submitted: 2019-11-12
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	implantology	Anyridge (Mega'Gen, Korea) 5° conical internal hexed connection
Group 2	implantology	Core (Bioimplant, Italy) 35° conical internal hexed connection (screw-vent style)

Primary Outcome Measures

Name	Time	Method
The width (MT) of the peri-implant mucosa	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.
height of the peri-implant mucosa (MH)	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.

Trial Locations

Locations (1)

University of Insubria; 🇮🇹 Varese, Italy