Central Incisors Narrow Implants in Alternative to Bone Augmentation With 4.2 mm Implants .

Study Overview
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Brief Summary
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Horizontal bone augmentation procedures are commonly used to increase bone width to allow the placement of dental implants or to improve aesthetics in deficient areas. Smaller diameter implants could be used instead in order to avoid bone augmentation procedures. The comparison between these two solutions will be evaluated in the trial.

Official Title
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3.2 mm Diameter Implants and Soft Tissue Grafts in Alternative to Horizontal Bone Augmentation for Placing 4.2 mm Diameter Implants at Central Incisors. A Multicenter Randomised Controlled Trial

Conditions
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Upper Central Incisor Edentulism

Intervention / Treatment
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* Device: ICE dental implant 4.2 mm
* Device: NICE dental implant 3.2 mm
* Device: Alpha Bio's Graft Bovine bone
* Device: Alpha Bio's Graft resorbable membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upper central incisor edentulism bone width between 3.5-4.5 mm requirement of only one implant supported crown patient is willing to sign an informed consent Exclusion Criteria: General contraindications to implant surgery. Immunosuppressed or immunocompromised patients Patients irradiated in the head and neck area. Patients with poor oral hygiene and motivation. Uncontrolled diabetes. Pregnancy or lactation. Addiction to alcohol or drugs. Untreated periodontal disease. Treated or under treatment with intravenous amino-biphosphonates. Poor oral hygiene and motivation. Psychiatric problems and/or unrealistic expectations. Acute infection (abscess) or suppuration in the area intended for implant placement. Patients referred only for implant placement if cannot be followed at the treatment centre. Patient unable to attend the follow-up controls for 3 years after implant loading. Patient included in other studies, if this protocol cannot be properly followed. Immediate post-extractive sites (to be eligible at least 3 months must have passed since extraction).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dental implant with bone augmentation<br>patients will be installed with ICE Dental implant 4.2 mm diameter with Alpha-Bio's grafts horizontal bone augmentation | Device: ICE dental implant 4.2 mm<br>* ICE dental implant 4.2 mm diameter<br>Device: Alpha Bio's Graft Bovine bone<br>* Alpha Bio's Graft Bovine Bone<br>Device: Alpha Bio's Graft resorbable membrane<br>* Alpha Bio's Graft resorbable collagen membrane<br>|
| Experimental: narrow implant<br>patients will be installed with NICE Dental implant 3.2 mm diameter | Device: NICE dental implant 3.2 mm<br>* NICE dental implant 4.2 mm diameter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone loss | bone loss level as will be measured from the radio-graphic images | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative implant survival | Counting number of survived implants at the end of the study | 2 years |