NCT03222219

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

July 17, 2017

Last Update Submit

August 27, 2019

Conditions

DENTAL IMPLANTATION

Keywords

dental implant insertional torque stability

Outcome Measures

Primary Outcomes (1)

  • insertional torque value

    registration of torque values with dedicated device

    during surgery

Secondary Outcomes (3)

  • radiographic assessment

    6 months after surgery

  • clinical assessment

    12 months after surgery

  • implant stability quotient

    during surgery

Study Arms (3)

low implant stability quotient

dental implant insertion with low torque values

Procedure: dental implant insertion

medium implant stability quotient

dental implant insertion with medium torque values

Procedure: dental implant insertion

high implant stability quotient

dental implant insertion with high torque values

Procedure: dental implant insertion

Interventions

dental implant insertionPROCEDURE

the registration of the torque values is discriminant for the group assignment after dental implant insertion

Also known as: torque and stability quotient
high implant stability quotientlow implant stability quotientmedium implant stability quotient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • psychological or psychiatric diseases;
  • abuse of alcohol or drug use;
  • unregulated periodontal disease;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (3)

  • 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.

    PMID: 27538921RESULT

  • 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.

    PMID: 27398182RESULT

  • 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.

    PMID: 29862286DERIVED

MeSH Terms

Interventions

Torque

Intervention Hierarchy (Ancestors)

Torsion, MechanicalMechanical PhenomenaPhysical Phenomena

Study Officials

  • Claudio Stacchi, Dr.

    Piezosurgery Academy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of the Academy

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 19, 2017

Study Start

January 15, 2017

Primary Completion

October 15, 2017

Study Completion

October 15, 2017

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)