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Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

Primary Purpose

Missing Teeth, Edentulous Alveolar Ridge, Tooth Loss

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
implant site preparation
Sponsored by
Luigi Canullo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth focused on measuring osteotomy, dental implant, marginal bone loss, implant stability, osteotome, implant site preparation

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Studio Odont.Associato Dr.P.Cicchese E L.CanulloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hybrid Funnel Technique

Conventional Technique

Arm Description

Hybrid funnel technique for implant site preparation

Conventional subtractive Drill technique for implant site preparation

Outcomes

Primary Outcome Measures

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
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
Implant stability
check implant stability using resonant frequency analysis (RFA)
Implant stability
check implant stability using resonant frequency analysis (RFA)
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)

Secondary Outcome Measures

Full Information

First Posted
August 10, 2022
Last Updated
August 12, 2022
Sponsor
Luigi Canullo
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1. Study Identification

Unique Protocol Identification Number
NCT05499533
Brief Title
Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation
Official Title
Hybrid Funnel Technique vs Conventional Drill Osteotomy, a Novel Approach for Implant Site Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luigi Canullo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth, Edentulous Alveolar Ridge, Tooth Loss
Keywords
osteotomy, dental implant, marginal bone loss, implant stability, osteotome, implant site preparation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Funnel Technique
Arm Type
Experimental
Arm Description
Hybrid funnel technique for implant site preparation
Arm Title
Conventional Technique
Arm Type
Active Comparator
Arm Description
Conventional subtractive Drill technique for implant site preparation
Intervention Type
Procedure
Intervention Name(s)
implant site preparation
Other Intervention Name(s)
osteotomy
Intervention Description
a hole were created in the edentulous ridge area before implant placement
Primary Outcome Measure Information:
Title
Marginal bone loss
Description
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
Time Frame
6 months after implant placement
Title
Marginal bone loss
Description
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
Time Frame
12 months after implant placement
Title
Implant stability
Description
check implant stability using resonant frequency analysis (RFA)
Time Frame
immediately after implant placement
Title
Implant stability
Description
check implant stability using resonant frequency analysis (RFA)
Time Frame
2 months after implant placement
Title
Insertion torque curve
Description
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)
Time Frame
During implant placement (T0 baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Canullo, DDS PhD
Phone
3476201976
Email
luigicanullo@yahoo.it
Facility Information:
Facility Name
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
City
Rome
State/Province
Italy/Rome
ZIP/Postal Code
00198
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, DDS PhD
Phone
+39 06 841 1980
Email
luigicanullo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Luigi Canullo, DDS PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31878016
Citation
Yeo IL. Modifications of Dental Implant Surfaces at the Micro- and Nano-Level for Enhanced Osseointegration. Materials (Basel). 2019 Dec 23;13(1):89. doi: 10.3390/ma13010089.
Results Reference
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PubMed Identifier
26584202
Citation
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.
Results Reference
background
PubMed Identifier
29140373
Citation
Toia M, Stocchero M, Cecchinato F, Corra 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.
Results Reference
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PubMed Identifier
21682844
Citation
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.
Results Reference
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PubMed Identifier
34208849
Citation
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):6994. doi: 10.3390/ijerph18136994.
Results Reference
background
PubMed Identifier
29537128
Citation
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.
Results Reference
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Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

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