Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

August 12, 2022 updated by: Luigi Canullo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Italy/Rome
      • Rome, Italy/Rome, Italy, 00198
        • Recruiting
        • Studio Odont.Associato Dr.P.Cicchese E L.Canullo
        • Contact:
        • Principal Investigator:
          • Luigi Canullo, DDS PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid Funnel Technique
Hybrid funnel technique for implant site preparation
Procedure: implant site preparation
a hole were created in the edentulous ridge area before implant placement
Other Names:
  • osteotomy
Active Comparator: Conventional Technique
Conventional subtractive Drill technique for implant site preparation
Procedure: implant site preparation
a hole were created in the edentulous ridge area before implant placement
Other Names:
  • osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after implant placement
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
12 months after implant placement
Implant stability
Time Frame: immediately after implant placement
check implant stability using resonant frequency analysis (RFA)
immediately after implant placement
Implant stability
Time Frame: 2 months after implant placement
check implant stability using resonant frequency analysis (RFA)
2 months after implant placement
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)
During implant placement (T0 baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luigi Canullo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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