Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499533
• Other study ID #: ABT3
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
• Contact: Luigi Canullo, DDS PhD
• Phone: 3476201976
• Email: luigicanullo[@]yahoo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anodontia
• Edentulous Alveolar Ridge
• Missing Teeth
• Tooth Loss

Intervention

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

Locations

Country	Name	City	State
Italy	Studio Odont.Associato Dr.P.Cicchese E L.Canullo	Rome	Italy/Rome

Sponsors (1)

Lead Sponsor	Collaborator
Luigi Canullo

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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). pii: 6994. doi: 10.3390/ijerph18136994. — View 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. — View Citation

Toia M, Stocchero M, Cecchinato F, Corrà 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Implant stability	check implant stability using resonant frequency analysis (RFA)	immediately after implant placement
Primary	Implant stability	check implant stability using resonant frequency analysis (RFA)	2 months after implant placement
Primary	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)