Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

Overview

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.

Full Title of Study: “Hybrid Funnel Technique vs Conventional Drill Osteotomy, a Novel Approach for Implant Site Preparation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2023

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.

Interventions

  • Procedure: implant site preparation
    • a hole were created in the edentulous ridge area before implant placement

Arms, Groups and Cohorts

  • Experimental: Hybrid Funnel Technique
    • Hybrid funnel technique for implant site preparation
  • Active Comparator: Conventional Technique
    • Conventional subtractive Drill technique for implant site preparation

Clinical Trial Outcome Measures

Primary Measures

  • Marginal bone loss
    • Time Frame: 6 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
  • Marginal bone loss
    • Time Frame: 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
  • Implant stability
    • Time Frame: immediately after implant placement
    • check implant stability using resonant frequency analysis (RFA)
  • Implant stability
    • Time Frame: 2 months after implant placement
    • check implant stability using resonant frequency analysis (RFA)
  • Insertion torque curve
    • Time Frame: 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)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Luigi Canullo
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Luigi Canullo, principal investigator – Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
  • Overall Contact(s)
    • Luigi Canullo, DDS PhD, 3476201976, luigicanullo@yahoo.it

References

Yeo IL. Modifications of Dental Implant Surfaces at the Micro- and Nano-Level for Enhanced Osseointegration. Materials (Basel). 2019 Dec 23;13(1). pii: E89. doi: 10.3390/ma13010089. Review.

Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.

Toia M, Stocchero M, Cecchinato F, CorrĂ  E, Jimbo R, Cecchinato D. Clinical Considerations of Adapted Drilling Protocol by Bone Quality Perception. Int J Oral Maxillofac Implants. 2017 Nov/Dec;32(6):1288-1295. doi: 10.11607/jomi.5881.

Stacchi C, Vercellotti T, Torelli L, Furlan F, Di Lenarda R. Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial. Clin Implant Dent Relat Res. 2013 Apr;15(2):188-97. doi: 10.1111/j.1708-8208.2011.00341.x. Epub 2011 Apr 19.

Ivanova V, Chenchev I, Zlatev S, Mijiritsky E. Correlation between Primary, Secondary Stability, Bone Density, Percentage of Vital Bone Formation and Implant Size. Int J Environ Res Public Health. 2021 Jun 30;18(13). pii: 6994. doi: 10.3390/ijerph18136994.

Alifarag AM, Lopez CD, Neiva RF, Tovar N, Witek L, Coelho PG. Atemporal osseointegration: Early biomechanical stability through osseodensification. J Orthop Res. 2018 Sep;36(9):2516-2523. doi: 10.1002/jor.23893. Epub 2018 Mar 30.

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