NCT04497571

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

July 28, 2020

Last Update Submit

August 1, 2020

Conditions

Dental ImplantsTooth Loss

Keywords

Dental implantsPiezoelectric osteotomyPiezoelectric surgeryImmediate load

Outcome Measures

Primary Outcomes (4)

  • Marginal Bone Loss

    To compare MBL measured using radiographs.

    1 month

  • Marginal Bone Loss

    To compare MBL measured using radiographs.

    3 months

  • Marginal Bone Loss

    To compare MBL measured using radiographs.

    6 months

  • Marginal Bone Loss

    To compare MBL measured using radiographs.

    12 months

Secondary Outcomes (5)

  • Primary stability

    Baseline

  • Secondary stability

    3 months

  • Probing depth

    3,6,12 months

  • Bleeding of probing

    3,6,12 months

  • Survival rate

    3,6,12 months

Study Arms (2)

Piezoelectric osteotomy

EXPERIMENTAL

Implant placement by piezoelectric osteotomy

Procedure: Piezoelectric osteotomy.

Conventional drilling

ACTIVE COMPARATOR

Implant placement by conventional drilling

Procedure: Conventional drilling

Interventions

Piezoelectric osteotomy.PROCEDURE

Implants placed using the ultrasonic technique.

Piezoelectric osteotomy
Conventional drillingPROCEDURE

Implants placed using drilling technique

Conventional drilling

Eligibility Criteria

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

You may qualify if:

  • Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isabel Godoy Reina

Almería, 04001, Spain

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trials.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Master of Periodontology and Implant Dentistry, PhD student.

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 4, 2020

Study Start

June 1, 2020

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations

ES(1)