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Status unknownNCT04497571Updated Aug 4, 2020

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

An interventional study of Piezoelectric osteotomy. and Conventional drilling in Dental Implants and Tooth Loss, sponsored by Universidad de Granada. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-04.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Dental Implants
  • Tooth Loss

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Keywords

  • Dental implants
  • Piezoelectric osteotomy
  • Piezoelectric surgery
  • Immediate load
03

In context

Tooth Loss

224 studies on the registry are indexed under Tooth Loss; 50 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 166 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Piezoelectric osteotomy

    Implant placement by piezoelectric osteotomy

    Procedure: Piezoelectric osteotomy.

  • Active comparator
    Conventional drilling

    Implant placement by conventional drilling

    Procedure: Conventional drilling

Interventions

  • ProcedurePiezoelectric osteotomy.

    Implants placed using the ultrasonic technique.

  • ProcedureConventional drilling

    Implants placed using drilling technique

06

What researchers measure

Primary outcomes

  1. Marginal Bone Loss

    To compare MBL measured using radiographs.

    Time frame: 1 month

  2. Marginal Bone Loss

    To compare MBL measured using radiographs.

    Time frame: 3 months

  3. Marginal Bone Loss

    To compare MBL measured using radiographs.

    Time frame: 6 months

  4. Marginal Bone Loss

    To compare MBL measured using radiographs.

    Time frame: 12 months

Secondary outcomes

  1. Primary stability

    Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.

    Time frame: Baseline

  2. Secondary stability

    Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.

    Time frame: 3 months

  3. 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.

    Time frame: 3,6,12 months

  4. 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.

    Time frame: 3,6,12 months

  5. Survival rate

    To measure implant success rate.

    Time frame: 3,6,12 months

07

Study locations

1 of 1 sites recruiting
  • Isabel Godoy Reina
    Almería, 04001, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04497571
Lead sponsor
Universidad de Granada
Responsible party
Isabel Godoy Reina (Professor of Master of Periodontology and Implant Dentistry, PhD student., Universidad de Granada) — Principal investigator
First posted
Aug 4, 2020
Start date
Jun 1, 2020
Primary completion
Apr 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Aug 4, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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