Implant Insertion Torque and Primary Stability (TorqueISQ)

August 27, 2019 updated by: Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Piezosurgery Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. indications for insertion of dental implants, based on careful diagnosis and treatment plan;
  2. presence of a residual bone crest with a height ≥ 11 mm and thickness ≥ 6 mm at the site of the implant site planned;
  3. the bone crest must be intact (at least 3 months after the loss / extraction of the corresponding dental element);
  4. age of the patient more than 18 years;
  5. patients should be able to examine and understand the protocol of study;
  6. informed consent.

Exclusion Criteria:

  1. acute myocardial infarction in the last six months;
  2. uncontrolled clotting disorders;
  3. unmanaged diabetes (HBA1c superior than 7.5%);
  4. radiotherapy in the head / neck district for the last 24 months;
  5. Immune compromise (HIV infection or chemotherapy over the last 3 years);
  6. active or past treatment with intravenous bisphosphonates;
  7. psychological or psychiatric diseases;
  8. abuse of alcohol or drug use;
  9. unregulated periodontal disease;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
low implant stability quotient
dental implant insertion with low torque values
Procedure: dental implant insertion
the registration of the torque values is discriminant for the group assignment after dental implant insertion
Other Names:
  • torque and stability quotient
medium implant stability quotient
dental implant insertion with medium torque values
Procedure: dental implant insertion
the registration of the torque values is discriminant for the group assignment after dental implant insertion
Other Names:
  • torque and stability quotient
high implant stability quotient
dental implant insertion with high torque values
Procedure: dental implant insertion
the registration of the torque values is discriminant for the group assignment after dental implant insertion
Other Names:
  • torque and stability quotient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
insertional torque value
Time Frame: during surgery
registration of torque values with dedicated device
during surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
radiographic assessment
Time Frame: 6 months after surgery
intra oral radiographs are produced for crestal bone assessment
6 months after surgery
clinical assessment
Time Frame: 12 months after surgery
clinical evaluation of the dental implant
12 months after surgery
implant stability quotient
Time Frame: during surgery
registration of implant stability quotient with dedicated device
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Piezosurgery Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TorqueISQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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