Influence of the Implant Connection on Facial Tissues Maturation

• Sponsor: University of Milan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04160689
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 8.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bone Loss; Periodontal Bone Loss; Implant Tissue Failure	Biological: implantology	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 1, 2018
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Insubria	Varese		Italy

Sponsors and Collaborators

• University of Milan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marco Farronato, Principal Investigator, University of Milan
• ClinicalTrials.gov Identifier: NCT04160689
• Other Study ID Numbers: 002
• First Posted: Nov 13, 2019
• Last Update Posted: Nov 14, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Alveolar Bone Loss

Study Results

No Results Posted as of Nov 14, 2019