Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

Study Overview
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Brief Summary
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Hybrid Funnel Technique arises from the union of subtractive and non-subtractive techniques for implant site preparation. Hybrid funnel technique is performed with specially designed drills and osteotome. the aim of the study is to examine marginal bone level and implant stability of implants inserted with two different techniques for the surgical implant site preparation.

Detailed Description
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Overtime several osteotomy techniques were described in literature for surgical implant site preparation and there is a clear dichotomy between expansive and ablative techniques. The ablative techniques imply the preparation of the implant socket by removing bone: drill osteotomy and ultrasonic osteotomy. Expansive technique for osteotomy has recently been proposed: the osseodensification. Osseodensification, a non-subtractive instrumentation method, involves the use of specific drills or manual osteotomes which determine an expansion of the implant site without bone removal and bone fragments compaction on the walls of implant socket.The aim of the present study is to propose a new approach for the implant site preparation that combines ablative and expansive techniques. The technique proposed is called hybrid funnel techniqueAlthough a variety of techniques are available for implant site preparation, the hypothesis is that Hybrid Funnel technique will be positively adopted to perform osteotomy, exploiting the cancellous bone elastic properties to stabilize the implant and avoiding to stress the cortical area. Primary objectives are to compare hybrid funnel technique and traditional technique on different bone densities and to examine Marginal Bone Level torque insertion value and Implant stability.

Official Title
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Hybrid Funnel Technique vs Conventional Drill Osteotomy, a Novel Approach for Implant Site Preparation

Conditions
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Missing Teeth, Edentulous Alveolar Ridge, Tooth Loss

Intervention / Treatment
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* Procedure: implant site preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient needing for post-extraction implant supported restoration in the mandibular or maxillary area ASA 1 E ASA 2 Subject is 30-85 years old Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%) Patients that are willing to sign an informed consent and participate in a clinical study Exclusion Criteria: Absence Type 1-2 post extraction sites Patient ASA 3 or 4 Any sites where an implant already failed sites Untreated Periodontitis Allergy declared to one or more medicaments to be used during treatment Pregnancy (confirmed by verbal inquiry)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Once selected, patients will be assigned to one of two treatment groups. (test group- hybrid funnel technique; control group- conventional drill technique) Patients are placed in one of the two treatment groups according to the chronological order in which they will be recruited. Age, sex, surgical implant site (upper, lower, anterior, posterior) and clinical l characteristics will be taken into account to obtain two homogeneous study groups. First Hybrid Funnel Technique will be performed, then Conventional drill Technique will be performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Funnel Technique<br>Hybrid funnel technique for implant site preparation | Procedure: implant site preparation<br>* a hole were created in the edentulous ridge area before implant placement<br>* Other names: osteotomy;|
| Active Comparator: Conventional Technique<br>Conventional subtractive Drill technique for implant site preparation | Procedure: implant site preparation<br>* a hole were created in the edentulous ridge area before implant placement<br>* Other names: osteotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost | 6 months after implant placement | 
| Marginal bone loss | Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost | 12 months after implant placement | 
| Implant stability | check implant stability using resonant frequency analysis (RFA) | immediately after implant placement | 
| Implant stability | check implant stability using resonant frequency analysis (RFA) | 2 months after implant placement | 
| Insertion torque curve | The Insertion torque data were recorded and exported as a curve The torque curve records the amount of energy that was needed for arrive at the positioning of the implantunit of measurement of torque is Newton centimeter (Ncm) | During implant placement (T0 baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteotomy, dental implant, marginal bone loss, implant stability, osteotome, implant site preparation