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

Primary Purpose

Dental Implants, Tooth Loss

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Piezoelectric osteotomy.
Conventional drilling
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implants focused on measuring Dental implants, Piezoelectric osteotomy, Piezoelectric surgery, Immediate load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Isabel Godoy ReinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Piezoelectric osteotomy

Conventional drilling

Arm Description

Implant placement by piezoelectric osteotomy

Implant placement by conventional drilling

Outcomes

Primary Outcome Measures

Marginal Bone Loss
To compare MBL measured using radiographs.
Marginal Bone Loss
To compare MBL measured using radiographs.
Marginal Bone Loss
To compare MBL measured using radiographs.
Marginal Bone Loss
To compare MBL measured using radiographs.

Secondary Outcome Measures

Primary stability
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.
Secondary stability
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.
Probing depth
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.
Bleeding of probing
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.
Survival rate
To measure implant success rate.

Full Information

First Posted
July 28, 2020
Last Updated
August 1, 2020
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT04497571
Brief Title
Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.
Official Title
Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implants, Tooth Loss
Keywords
Dental implants, Piezoelectric osteotomy, Piezoelectric surgery, Immediate load

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trials.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piezoelectric osteotomy
Arm Type
Experimental
Arm Description
Implant placement by piezoelectric osteotomy
Arm Title
Conventional drilling
Arm Type
Active Comparator
Arm Description
Implant placement by conventional drilling
Intervention Type
Procedure
Intervention Name(s)
Piezoelectric osteotomy.
Intervention Description
Implants placed using the ultrasonic technique.
Intervention Type
Procedure
Intervention Name(s)
Conventional drilling
Intervention Description
Implants placed using drilling technique
Primary Outcome Measure Information:
Title
Marginal Bone Loss
Description
To compare MBL measured using radiographs.
Time Frame
1 month
Title
Marginal Bone Loss
Description
To compare MBL measured using radiographs.
Time Frame
3 months
Title
Marginal Bone Loss
Description
To compare MBL measured using radiographs.
Time Frame
6 months
Title
Marginal Bone Loss
Description
To compare MBL measured using radiographs.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Primary stability
Description
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.
Time Frame
Baseline
Title
Secondary stability
Description
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.
Time Frame
3 months
Title
Probing depth
Description
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.
Time Frame
3,6,12 months
Title
Bleeding of probing
Description
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.
Time Frame
3,6,12 months
Title
Survival rate
Description
To measure implant success rate.
Time Frame
3,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Isabel Godoy Reina
City
Almería
ZIP/Postal Code
04001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Godoy Reina
Phone
661070242
Email
igodorei@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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