Jaw, Edentulous, Partially Clinical Trial
Official title:
Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
Verified date | September 2016 |
Source | Proed |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Aim of the present study will be to evaluate if the platform switching and the flat abutment
can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft
tissues will also be provided.
80 consecutively inserted dental implants will be included in this study. Maxillary and
mandibular implants will be considered, both in frontal and posterior area. After 6 to 12
weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented.
After 2 more months, the definitive porcelain crown will be delivered. The final outcomes
will be collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation
T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants
each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3
Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants +
GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays,
the mesial and distal Marginal Bone Level will be measured and compared among and between
the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured
at T0, T1, T2 and T3. Data will be statistically analyzed.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 2015 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Healthy adult patients with partial edentulism Exclusion Criteria: - Current pregnant patients - History of malignancy - History of radiotherapy or chemiotherapy in the last 5 years - Long term steroidal or antibiotic therapy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | PROED, Institute for Professional Education in Dentistry | Torino | TO |
Lead Sponsor | Collaborator |
---|---|
Proed |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Marginal Bone Level | On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured | 1 year after implant installation | No |
Secondary | Probing Pocket Depth | Probing depth measured mesially, buccaly, distally and lingually at implant site | 1 year after implant installation | No |
Secondary | Bleeding on Probing | Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site | 1 year after implant installation | No |
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