Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.

August 1, 2020 updated by: Isabel Godoy Reina, Universidad de Granada

Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.

Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.

Study Overview

Status

Status

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

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

Main goals.

Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.

Specific goals.

  • Evaluate the marginal peri-implant bone loss after the healing period through radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year after the implants insertion.
  • Evaluate the primary stability of each individual implant the day of their insertion to verify their load on the moment of surgery and also compare the values of each preparation techniques of implant bone preparation.
  • Evaluate the secondary stability of each individual implant and compare the values of each preparation techniques.
  • Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.

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.
Interventional

Enrollment (Anticipated)

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.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Spain
      • Almería, Spain, 04001
        • Recruiting
        • Isabel Godoy Reina
        • Contact:

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

Description

Inclusion Criteria:

  • Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.
  • 3 months after the dental extraction without alveolar scar tissue remains.
  • Bone availability of at least 5mm of width and 13mm of length.
  • At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant biological width.
  • Oclusal pattern that ensures prosthetic success.
  • Implants need to have at least a 35 N and 70 ISQ index to be loaded.
  • Index of plaque < 20% and/or inactive periodontal disease.

Exclusion Criteria:

  • Acute myocardial infarction in the last 2 months.
  • Uncontrolled coagulation disorders
  • Uncontrolled diabetes (HbA1c> 7.5%).
  • Radiotherapy on head/neck in the last 24 months.
  • Immunocompromised patient.
  • History of medication related to osteonecrosis of the jaws.
  • Psychiatric disorders, alcohol, drugs and large smokers (>10 cigarrillos).
  • Plaque index > 20%.
  • Need for simultaneous or previous peri-implant guided bone regeneration procedures.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: Piezoelectric osteotomy
Implant placement by piezoelectric osteotomy
Procedure: Piezoelectric osteotomy.
Implants placed using the ultrasonic technique.
Active Comparator: Conventional drilling
Implant placement by conventional drilling
Procedure: Conventional drilling
Implants placed using drilling technique

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
Marginal Bone Loss
Time Frame: 1 month
To compare MBL measured using radiographs.
1 month
Marginal Bone Loss
Time Frame: 3 months
To compare MBL measured using radiographs.
3 months
Marginal Bone Loss
Time Frame: 6 months
To compare MBL measured using radiographs.
6 months
Marginal Bone Loss
Time Frame: 12 months
To compare MBL measured using radiographs.
12 months

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
Primary stability
Time Frame: Baseline
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.
Baseline
Secondary stability
Time Frame: 3 months
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.
3 months
Probing depth
Time Frame: 3,6,12 months
Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
3,6,12 months
Bleeding of probing
Time Frame: 3,6,12 months
Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
3,6,12 months
Survival rate
Time Frame: 3,6,12 months
To measure implant success rate.
3,6,12 months

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.
Universidad de Granada

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.
June 1, 2020

Primary Completion (Anticipated)

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.
April 1, 2022

Study Completion (Anticipated)

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.
December 1, 2022

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 28, 2020

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.
August 1, 2020

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.
August 4, 2020

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 4, 2020

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 1, 2020

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, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • IGR UGranada

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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