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

NCT ID: NCT04497571

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Implants Tooth Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trials.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Piezoelectric osteotomy

Implant placement by piezoelectric osteotomy

Group Type EXPERIMENTAL

Piezoelectric osteotomy.

Intervention Type PROCEDURE

Implants placed using the ultrasonic technique.

Conventional drilling

Implant placement by conventional drilling

Group Type ACTIVE_COMPARATOR

Conventional drilling

Intervention Type PROCEDURE

Implants placed using drilling technique

Interventions

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Piezoelectric osteotomy.

Implants placed using the ultrasonic technique.

Intervention Type PROCEDURE

Conventional drilling

Implants placed using drilling technique

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Isabel Godoy Reina

Professor of Master of Periodontology and Implant Dentistry, PhD student.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isabel Godoy Reina

Almería, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Isabel Godoy Reina

Role: primary

661070242

Other Identifiers

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IGR UGranada

Identifier Type: -

Identifier Source: org_study_id

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