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Clinical Trials/NCT04497571
NCT04497571
Unknown
Not Applicable

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

Universidad de Granada1 site in 1 country30 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implants
Sponsor
Universidad de Granada
Enrollment
30
Locations
1
Primary Endpoint
Marginal Bone Loss
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
December 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Isabel Godoy Reina

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

Universidad de Granada

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Marginal Bone Loss

Time Frame: 12 months

To compare MBL measured using radiographs.

Secondary Outcomes

  • Primary stability(Baseline)
  • Bleeding of probing(3,6,12 months)
  • Secondary stability(3 months)
  • Survival rate(3,6,12 months)
  • Probing depth(3,6,12 months)

Study Sites (1)

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