Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

Not Applicable

• Conditions: Tooth Loss; Missing Teeth; Edentulous Alveolar Ridge
• Interventions: Procedure: implant site preparation

• Registration Number: NCT05499533
• Lead Sponsor: Luigi Canullo

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-07-29
• Status Verified: 2022-08
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-16
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patient needing for post-extraction implant supported restoration in the mandibular or maxillary area
2. ASA 1 E ASA 2
3. Subject is 30-85 years old
4. Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
5. Patients that are willing to sign an informed consent and participate in a clinical study

Exclusion Criteria

1. Absence Type 1-2 post extraction sites
2. Patient ASA 3 or 4
3. Any sites where an implant already failed sites
4. Untreated Periodontitis
5. Allergy declared to one or more medicaments to be used during treatment
6. Pregnancy (confirmed by verbal inquiry)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid Funnel Technique	implant site preparation	Hybrid funnel technique for implant site preparation
Conventional Technique	implant site preparation	Conventional subtractive Drill technique for implant site preparation

Primary Outcome Measures

Name	Time	Method
Insertion torque curve	During implant placement (T0 baseline)	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)
Implant stability	2 months after implant placement	check implant stability using resonant frequency analysis (RFA)
Marginal bone loss	12 months after implant placement	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

Trial Locations

Locations (1)

Studio Odont.Associato Dr.P.Cicchese E L.Canullo; 🇮🇹 Rome, Italy/Rome, Italy