Clinical trial NCT05499533: 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
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Edentulous Alveolar Ridge
Tooth Loss
Keywords: osteotomy
dental implant
marginal bone loss
implant stability
osteotome
implant site preparation
Lead sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Marginal bone loss
timeFrame: 6 months after implant placement
measure: Marginal bone loss
timeFrame: 12 months after implant placement
measure: Implant stability
timeFrame: immediately after implant placement
measure: Implant stability
timeFrame: 2 months after implant placement
measure: Insertion torque curve
timeFrame: During implant placement (T0 baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Studio Odont.Associato Dr.P.Cicchese E L.Canullo
state: Italy/Rome
Study officials:
References:
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.
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.
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.
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.
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.
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.