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Completed

NCT Number: NCT05499533

Hybrid Funnel Technique a Innovative Technique 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.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Edentulous Alveolar Ridge Mouth Diseases Periodontal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases Tooth Loss

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Rome, Italy/Rome, 00198, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

implant site preparation

Procedure

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

Other names: osteotomy

Primary outcomes

  1. 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

  2. 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

  3. Implant stability

    Time frame: immediately after implant placement

    check implant stability using resonant frequency analysis (RFA)

  4. Implant stability

    Time frame: 2 months after implant placement

    check implant stability using resonant frequency analysis (RFA)

  5. 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)

Sponsors and collaborators

Lead sponsor

Luigi Canullo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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