Influence of the Implant Connection on Facial Tissues Maturation
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
1 other identifier
interventional
104
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2018
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 9, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedNovember 14, 2019
November 1, 2019
1 year
November 9, 2019
November 12, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Group 1
ACTIVE COMPARATORAnyridge (Mega'Gen, Korea) 5° conical internal hexed connection
Group 2
ACTIVE COMPARATORCore (Bioimplant, Italy) 35° conical internal hexed connection (screw-vent style)
Interventions
Eligibility Criteria
You may qualify if:
- Missing teeth
- good oral hygiene
- good systemic health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Insubria
Varese, Italy
Related Publications (1)
Farronato D, Pasini PM, Manfredini M, Scognamiglio C, Orsina AA, Farronato M. Influence of the implant-abutment connection on the ratio between height and thickness of tissues at the buccal zenith: a randomized controlled trial on 188 implants placed in 104 patients. BMC Oral Health. 2020 Feb 17;20(1):53. doi: 10.1186/s12903-020-1037-5.
PMID: 32066431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2019
First Posted
November 13, 2019
Study Start
November 1, 2018
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
November 14, 2019
Record last verified: 2019-11