DENTAL IMPLANTATIONTorqueISQNCT03222219
Implant Insertion Torque and Primary Stability
An observational study of DENTAL IMPLANTATION, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
The objective of this observational study is to evaluate the primary stability of dental implants. Clinical insertion torque data with the Implant Stability Quotient will be correlated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- DENTAL IMPLANTATION
- What is being tested?
- dental implant insertion
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2017to 15 Oct 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population was composed of all patients presenting for evaluation and management of any single edentulism requiring single dental implant insertion with healed bone crest and sufficient recipient bone. To be included in the study sample, patients had to present a residual crestal height more than 11 mm, wider more than 6 mm and to be 18 years or older, and able to understand and sign a written informed consent form.
Who may be able to join
- indications for insertion of dental implants, based on careful diagnosis and treatment plan;
- presence of a residual bone crest with a height ≥ 11 mm and thickness ≥ 6 mm at the site of the implant site planned;
- the bone crest must be intact (at least 3 months after the loss / extraction of the corresponding dental element);
- age of the patient more than 18 years;
- patients should be able to examine and understand the protocol of study;
- informed consent.
Who cannot join
- acute myocardial infarction in the last six months;
- uncontrolled clotting disorders;
- unmanaged diabetes (HBA1c superior than 7.5%);
- radiotherapy in the head / neck district for the last 24 months;
- Immune compromise (HIV infection or chemotherapy over the last 3 years);
- active or past treatment with intravenous bisphosphonates;
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- psychological or psychiatric diseases;
- abuse of alcohol or drug use;
- unregulated periodontal disease;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Implant Insertion Torque on the Primary Stability of Tapered Dental Implants With Deep Spires
The objective of this observational study is to evaluate the primary stability of dental implants. Clinical insertion torque data with the Implant Stability Quotient will be correlated.
Read the detailed description
In the healing of long bone fractures, the absence of movement between the two parts of the fracture is essential for good healing: the movement, even at the micrometric level, can generate stress and tensions that prevent bone apposition in the gap. Even the primary stability of a dental implant is one of the main preconditions for osseointegration: in fact, during healing, micromovies that exceed the threshold of 100-150 microns can stimulate the growth of fibrous tissue in the bone to implant interface, leading to the failure of the procedure.
It is also known that primary implant stability tends to decrease in the first weeks after placement due to inflammatory response due to surgical trauma before rising when bone recoating phenomena begin to prevail over reabsorption. Attention to implant stability is a crucial factor, especially in cases where immediate or early loading procedures are in place: system stress during chewing or simply related to tongue, cheeks or lips movements can result in micromovements that may lead to the failure of the procedure.
With these assumptions, it is evident that a tool that allows the clinician to have a reliable evaluation of implant stability is the most important one: currently in use are the measurement of the insertion torque of the implant and the resonance frequency analysis. The insertion torque can be defined as the measurement of the resistance that the system encounters during its advancement in the apical direction by means of a rotating movement on its axis. Resonance frequency analysis is a not invasive method that evaluates rigidity of the bone system by measuring the size of the implant movement under a lateral force. High insertion torques have been proposed as a first rate technique to achieve a great implant stability, especially in cases to be treated with immediate or early load; Other studies point out that excessive insertion torques can cause both biological problems and mechanical to the implant.
However, the relationship between insertion torque and implant stability is unclear: according to some in vitro studies, the two elements would be in direct relation, while others would be independent.
The purpose of this prospective study is to evaluate in vivo the relationship between insertion torque value and implant stability measured using resonance frequency analysis in dental implants with a deep spire conical design.
- Conditions
- DENTAL IMPLANTATION
- Being tested
- dental implant insertion
- Keywords
- dental implant insertional torque stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant insertionProcedure or surgery
Also called torque and stability quotient
the registration of the torque values is discriminant for the group assignment after dental implant insertion
| Study group | Role | What they receive |
|---|---|---|
| low implant stability quotient | dental implant insertion with low torque values Receives: Procedure: dental implant insertion | |
| medium implant stability quotient | dental implant insertion with medium torque values Receives: Procedure: dental implant insertion | |
| high implant stability quotient | dental implant insertion with high torque values Receives: Procedure: dental implant insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertional torque value
registration of torque values with dedicated device
Measured: during surgery
Secondary outcomes (3)
radiographic assessment
intra oral radiographs are produced for crestal bone assessment
Measured: 6 months after surgery
clinical assessment
clinical evaluation of the dental implant
Measured: 12 months after surgery
implant stability quotient
registration of implant stability quotient with dedicated device
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start15 Jan 2017
- Primary completion15 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DENTAL IMPLANTATIONStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- Claudio Stacchi, Dr., Principal investigator, Piezosurgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222219
- Sponsor's protocol ID
- TorqueISQ
- Acronym
- TorqueISQ
- Status last verified
- Aug 2019
- First submitted
- 17 Jul 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acil Y, Sievers J, Gulses A, Ayna M, Wiltfang J, Terheyden H. Correlation between resonance frequency, insertion torque and bone-implant contact in self-cutting threaded implants. Odontology. 2017 Jul;105(3):347-353. doi: 10.1007/s10266-016-0265-2. Epub 2016 Aug 18.
PubMed 27538921Santamaria-Arrieta G, Brizuela-Velasco A, Fernandez-Gonzalez FJ, Chavarri-Prado D, Chento-Valiente Y, Solaberrieta E, Dieguez-Pereira M, Vega JA, Yurrebaso-Asua J. Biomechanical evaluation of oversized drilling technique on primary implant stability measured by insertion torque and resonance frequency analysis. J Clin Exp Dent. 2016 Jul 1;8(3):e307-11. doi: 10.4317/jced.52873. eCollection 2016 Jul.
PubMed 27398182Baldi D, Lombardi T, Colombo J, Cervino G, Perinetti G, Di Lenarda R, Stacchi C. Correlation between Insertion Torque and Implant Stability Quotient in Tapered Implants with Knife-Edge Thread Design. Biomed Res Int. 2018 May 15;2018:7201093. doi: 10.1155/2018/7201093. eCollection 2018.
PubMed 29862286
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Implant Insertion Torque on the Primary Stability of Tapered Dental Implants With Deep Spires
- ClinicalTrials.gov ID
- NCT03222219
- Acronym / sponsor ID
- TorqueISQ / TorqueISQ
- Conditions
- DENTAL IMPLANTATION
- Keywords
- dental implant insertional torque stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 19 Jul 2017 (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.
The objective of this observational study is to evaluate the primary stability of dental implants. Clinical insertion torque data with the Implant Stability Quotient will be correlated.
Detailed description
In the healing of long bone fractures, the absence of movement between the two parts of the fracture is essential for good healing: the movement, even at the micrometric level, can generate stress and tensions that prevent bone apposition in the gap. Even the primary stability of a dental implant is one of the main preconditions for osseointegration: in fact, during healing, micromovies that exceed the threshold of 100-150 microns can stimulate the growth of fibrous tissue in the bone to implant interface, leading to the failure of the procedure.
It is also known that primary implant stability tends to decrease in the first weeks after placement due to inflammatory response due to surgical trauma before rising when bone recoating phenomena begin to prevail over reabsorption. Attention to implant stability is a crucial factor, especially in cases where immediate or early loading procedures are in place: system stress during chewing or simply related to tongue, cheeks or lips movements can result in micromovements that may lead to the failure of the procedure.
With these assumptions, it is evident that a tool that allows the clinician to have a reliable evaluation of implant stability is the most important one: currently in use are the measurement of the insertion torque of the implant and the resonance frequency analysis. The insertion torque can be defined as the measurement of the resistance that the system encounters during its advancement in the apical direction by means of a rotating movement on its axis. Resonance frequency analysis is a not invasive method that evaluates rigidity of the bone system by measuring the size of the implant movement under a lateral force. High insertion torques have been proposed as a first rate technique to achieve a great implant stability, especially in cases to be treated with immediate or early load; Other studies point out that excessive insertion torques can cause both biological problems and mechanical to the implant.
However, the relationship between insertion torque and implant stability is unclear: according to some in vitro studies, the two elements would be in direct relation, while others would be independent.
The purpose of this prospective study is to evaluate in vivo the relationship between insertion torque value and implant stability measured using resonance frequency analysis in dental implants with a deep spire conical design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low implant stability quotient | – | Procedure: dental implant insertiondental implant insertion with low torque values |
| medium implant stability quotient | – | Procedure: dental implant insertiondental implant insertion with medium torque values |
| high implant stability quotient | – | Procedure: dental implant insertiondental implant insertion with high torque values |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was composed of all patients presenting for evaluation and management of any single edentulism requiring single dental implant insertion with healed bone crest and sufficient recipient bone. To be included in the study sample, patients had to present a residual crestal height more than 11 mm, wider more than 6 mm and to be 18 years or older, and able to understand and sign a written informed consent form.
Key inclusion criteria (6 listed)
- indications for insertion of dental implants, based on careful diagnosis and treatment plan;
- presence of a residual bone crest with a height ≥ 11 mm and thickness ≥ 6 mm at the site of the implant site planned;
- the bone crest must be intact (at least 3 months after the loss / extraction of the corresponding dental element);
- age of the patient more than 18 years;
- patients should be able to examine and understand the protocol of study;
Key exclusion criteria (9 listed)
- acute myocardial infarction in the last six months;
- uncontrolled clotting disorders;
- unmanaged diabetes (HBA1c superior than 7.5%);
- radiotherapy in the head / neck district for the last 24 months;
- Immune compromise (HIV infection or chemotherapy over the last 3 years);
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 |
|---|---|---|
| dental implant insertionAlso: torque and stability quotientthe registration of the torque values is discriminant for the group assignment after dental implant insertion | Procedure or surgery | high implant stability quotient, low implant stability quotient, medium implant stability quotient |
Primary outcome
insertional torque value
Time frame: during surgery
registration of torque values with dedicated device
3 secondary outcomes
radiographic assessment
Time frame: 6 months after surgery
clinical assessment
Time frame: 12 months after surgery
implant stability quotient
Time frame: during surgery
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 28 Aug 2019.
- Results publication: PubMed 27538921Acil Y, Sievers J, Gulses A, Ayna M, Wiltfang J, Terheyden H. Correlation between resonance frequency, insertion torque and bone-implant contact in self-cutting threaded implants. Odontology. 2017 Jul;105(3):347-353. doi: 10.1007/s10266-016-0265-2. Epub 2016 Aug 18.
- Results publication: PubMed 27398182Santamaria-Arrieta G, Brizuela-Velasco A, Fernandez-Gonzalez FJ, Chavarri-Prado D, Chento-Valiente Y, Solaberrieta E, Dieguez-Pereira M, Vega JA, Yurrebaso-Asua J. Biomechanical evaluation of oversized drilling technique on primary implant stability measured by insertion torque and resonance frequency analysis. J Clin Exp Dent. 2016 Jul 1;8(3):e307-11. doi: 10.4317/jced.52873. eCollection 2016 Jul.
- Derived from this study: PubMed 29862286Baldi D, Lombardi T, Colombo J, Cervino G, Perinetti G, Di Lenarda R, Stacchi C. Correlation between Insertion Torque and Implant Stability Quotient in Tapered Implants with Knife-Edge Thread Design. Biomed Res Int. 2018 May 15;2018:7201093. doi: 10.1155/2018/7201093. eCollection 2018.
- 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.
Claudio Stacchi, Dr. principal investigator
Piezosurgery Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DENTAL IMPLANTATION, run by International Piezosurgery Academy 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 6 inclusion and 9 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 28 Aug 2019. 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?
insertional torque value (time frame: during surgery). 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 NCT03222219, which also lists 3 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 28 Aug 2019.