Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation

NCT05499533 | Completed DMC

• 1 other identifier: ABT3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Missing Teeth; Edentulous Alveolar Ridge; Tooth Loss

Keywords

osteotomy; dental implant; marginal bone loss; implant stability; osteotome; implant site preparation

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Implant stability

  check implant stability using resonant frequency analysis (RFA)

  immediately after implant placement

• Implant stability

  check implant stability using resonant frequency analysis (RFA)

  2 months after implant placement

• 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)

Study Arms (2)

Hybrid Funnel Technique

EXPERIMENTAL

Hybrid funnel technique for implant site preparation

Procedure: implant site preparation

Conventional Technique

ACTIVE COMPARATOR

Conventional subtractive Drill technique for implant site preparation

Procedure: implant site preparation

Interventions

implant site preparation PROCEDURE

a hole were created in the edentulous ridge area before implant placement

Also known as: osteotomy

Conventional Technique; Hybrid Funnel Technique

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Luigi Canullo: lead

Study Sites (1)

Studio Odont.Associato Dr.P.Cicchese E L.Canullo

Rome, Italy/Rome, 00198, Italy

Location

Related Publications (6)

• 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.

  PMID: 31878016 BACKGROUND

• 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.

  PMID: 26584202 BACKGROUND

• 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.

  PMID: 29140373 BACKGROUND

• 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.

  PMID: 21682844 BACKGROUND

• 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.

  PMID: 34208849 BACKGROUND

• 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.

  PMID: 29537128 BACKGROUND

MeSH Terms

Conditions

Anodontia; Tooth Loss

Interventions

Osteotomy

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: July 29, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)