Missing TeethNCT05499533
Hybrid Funnel Technique a Innovative Technique for Implant Site Preparation
A study testing implant site preparation in people with Missing Teeth and Edentulous Alveolar Ridge, run by Luigi Canullo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth, Edentulous Alveolar Ridge, Tooth Loss
- What is being tested?
- implant site preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Studio Odont.Associato Dr.P.Cicchese E L.Canullo
Rome, Italy/Rome, 00198
About this study
Official title: Hybrid Funnel Technique vs Conventional Drill Osteotomy, a Novel Approach 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.
Read the 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.
- Conditions
- Missing Teeth, Edentulous Alveolar Ridge, Tooth Loss
- Being tested
- implant site preparation
- Keywords
- osteotomy, dental implant, marginal bone loss, implant stability, osteotome, implant site preparation
- Medical subject headings
- Anodontia, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant site preparationProcedure or surgery
Also called osteotomy
a hole were created in the edentulous ridge area before implant placement
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Funnel Technique | Experimental | Hybrid funnel technique for implant site preparation Receives: Procedure: implant site preparation |
| Conventional Technique | Active comparator | Conventional subtractive Drill technique for implant site preparation Receives: Procedure: implant site preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months after implant placement
Implant stability
check implant stability using resonant frequency analysis (RFA)
Measured: immediately after implant placement
Implant stability
check implant stability using resonant frequency analysis (RFA)
Measured: 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)
Measured: During implant placement (T0 baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start29 Jul 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Missing TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luigi Canullo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luigi Canullo, Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499533
- Sponsor's protocol ID
- ABT3
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2022
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31878016Trisi 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.
PubMed 26584202Toia 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.
PubMed 29140373Stacchi 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.
PubMed 21682844Ivanova 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.
PubMed 34208849Alifarag 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.
PubMed 29537128
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Funnel Technique vs Conventional Drill Osteotomy, a Novel Approach for Implant Site Preparation
- ClinicalTrials.gov ID
- NCT05499533
- Acronym / sponsor ID
- ABT3
- Conditions
- Missing Teeth, Edentulous Alveolar Ridge, Tooth Loss
- Keywords
- osteotomy, dental implant, marginal bone loss, implant stability, osteotome, implant site preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Luigi CanulloUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Funnel Technique | Experimental | Procedure: implant site preparationHybrid funnel technique for implant site preparation |
| Conventional Technique | Active comparator | Procedure: implant site preparationConventional subtractive Drill technique for implant site preparation |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant site preparationAlso: osteotomya hole were created in the edentulous ridge area before implant placement | Procedure or surgery | Conventional Technique, Hybrid Funnel Technique |
Primary outcome
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
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
Implant stability
Time frame: immediately after implant placement
check implant stability using resonant frequency analysis (RFA)
Implant stability
Time frame: 2 months after implant placement
check implant stability using resonant frequency analysis (RFA)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 31878016Yeo 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.
- Background: PubMed 26584202Trisi 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.
- Background: PubMed 29140373Toia 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.
- Background: PubMed 21682844Stacchi 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.
- Background: PubMed 34208849Ivanova 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.
- Background: PubMed 29537128Alifarag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant site preparation in people with Missing Teeth and Edentulous Alveolar Ridge, run by Luigi Canullo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (time frame: 6 months after implant placement). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499533, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.