Implant Insertion Torque and Primary Stability (TorqueISQ)

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: Completed
• Conditions: DENTAL IMPLANTATION
• Intervention / Treatment: Procedure: dental implant insertion

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: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43100
    • Piezosurgery Academy

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
insertional torque value	registration of torque values with dedicated device	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic assessment	intra oral radiographs are produced for crestal bone assessment	6 months after surgery
clinical assessment	clinical evaluation of the dental implant	12 months after surgery
implant stability quotient	registration of implant stability quotient with dedicated device	during surgery

Collaborators and Investigators

• Sponsor: International Piezosurgery Academy

Publications and helpful links

General 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.
• Santamaria-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.
• Baldi 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): October 15, 2017
• Study Completion (Actual): October 15, 2017

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: dental implant insertional torque stability
• Other Study ID 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