Completed

Horizontal and Vertical Dimensional Changes of Peri-implant Facial Bone Following Placement of T3 Implants: a 1-year Cone Beam Computed Tomography Study

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What is being tested

implant insertion and abutment connection

+ osseointegrated implant

+ implant insertion and abutment connection

ProcedureDevice
Who is being recruted

Jaw Diseases+5

+ Jaw, Edentulous

+ Stomatognathic Diseases

From 18 to 90 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorProed, Torino, Italy
Last updated: September 2, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The long term results and benefit of implant insertion in the aesthetic area have been well documented. In the past few years, facial dimensional changes to the alveolar process following implant placement are object os study for both humans and animals investigations Recent studies suggest that platform switching decreases bone loss by 30% to 50%. It seems that the creation of a biologic width affects peri-implant bone loss to a significant extent and that platform switching is effective when the mucosal thickness allows the establishment of an horizontal biologic width. A new implant with an hybrid surface (T3) has been recently launched by Biomet 3i.Aim of the present study will be to evaluate the degree of 3D marginal bone remodelling around T3 Prevail implants. MATERIALS & METHODS: 40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic area (from second premolar to second premolar) will be enrolled in the study. At the time of surgery, a full thickness flap will be elevated, the implant bed will be prepared according to the manufacturer's instruction and the implants will be then seated into the bone. Implants can be placed both with a single-stage or two-stage procedure. Implants inserted with a two-stage procedure will be re-opened after a submerged period of three months. T0 corresponds to the time of implant insertion, T1 to the time of healing abutment's connection (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from healing abutment's connection. It is supposed that the creation of the biological width starts with the healing abutment's connection. CBCT scans will be taken immediately after abutment connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be identified, and measurements will be made at predetermined levels. Horizontal facial bone thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular distance from the implant platform to the most coronal point of the facial bone. Changes between T1 and T2 will be calculated.

Principal SponsorProed, Torino, Italy
Last updated: September 2, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Jaw DiseasesJaw, EdentulousStomatognathic DiseasesMouth DiseasesMouth, EdentulousMusculoskeletal DiseasesTooth DiseasesJaw, Edentulous, Partially

Criteria

Inclusion Criteria: Healthy adult patients requiring implant insertion - Exclusion Criteria: Pregnancy history of malignancy history of radiotherapy or chemotherapy in the last 5 years long term steroidal or antibiotic therapy -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
osseointegrated implant insertion and abutment connection Implants inserted in healed ridge, prosthetic connection with switching platform

Group II

Active Comparator
osseointegrated implant insertion and abutment connection Implants inserted in immediate post-extraction sites, prosthetic connection with switching platform

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

PROED, Institute for Professional Education in Dentistry

Torino, ItalyOpen PROED, Institute for Professional Education in Dentistry in Google Maps
CompletedOne Study Center