Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces.

Study Overview
=================
Brief Summary
-----------------
Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.

Official Title
-----------------
Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants Having Either Machined, SLA Medium Roughness, Nanostructured Calcium-Incorporated or Plasma Reactivated Nanostructured Calcium-Incorporated Surface: A Histologic Study.

Conditions
-----------------
Implant Geometry

Intervention / Treatment
-----------------
* Procedure: Implant placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm. Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval. Healed bone crest (≥ 3 months elapsed after extraction or tooth loss). Age > 18 years. Ability to examine and fully understand the study protocol. Exclusion Criteria: • Myocardial infarction within the past 6 months. Poorly controlled diabetes (HBA1c > 7.5%). Coagulation disorders. Radiotherapy to the head/neck area within the past two years. Present or past treatment with intravenous bisphosphonates. Immunocompromised patients. Psychological or psychiatric problems. Alcohol or drug abuse. Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%). Uncontrolled periodontal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xpeed<br>Implant with Xpeed surface | Procedure: Implant placement<br>* Implant placement with different surface types<br>|
| Active Comparator: SLA surface<br>Implant with SLA surface | Procedure: Implant placement<br>* Implant placement with different surface types<br>|
| Placebo Comparator: Machined<br>Implant with machined surface | Procedure: Implant placement<br>* Implant placement with different surface types<br>|
| Active Comparator: XPEEDActive<br>Implant with plasma treatment reactivated XPEED implant surface | Procedure: Implant placement<br>* Implant placement with different surface types<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone to implant contact | Histology technique on specimen retrieved containing mini-implants and bone surrounding it | 4 weeks healing period after implant placement | 
| Bone to implant contact | Histology technique on specimen retrieved containing mini-implants and bone surrounding it | 6 weeks healing period after implant placement |