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CompletedNCT06294171Updated Mar 5, 2024

Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone

An interventional study of measurement of alveolar ridge width in Dental Implant Failed, sponsored by University of Baghdad. Completed at 1 site in Iraq. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Nov 2022, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The aim of the study is to determine the efficacy of modified piezosurgery with osseodensification drills in expanding narrow alveolar bone.

Read the detailed description

Atrophic maxilla or mandible can lead to lack of prosthesis retention because of an inadequate bearing area causing both functional and physiological problems for patient, these problems can be treated for patient satisfaction with an implant supported fixed or removable complete or partial denture. Atrophic edentulous jaws can represent a significant challenge to the successful use of endosseous implants for prosthetic reconstruction of the edentulous mandible.

A collapsed alveolar ridge demonstrating a narrow width (less than 5 mm in many cases) and grossly adequate alveolar height is the most common candidate for the RSP.

Beginners in RSP should initially choose a 4-5 mm thickness of an even maxillary alveolar ridge and strive to almost double it in width.

A 3-mm alveolar ridge generally consists of 3 thin bone layers (in a horizontal sandwich fashion): 2 cortical plates (about 1 mm each) separated by 1 cancellous layer (about 1 mm). The wider the cancellous bone layer (the layer where the split is done), the easier it will be to accomplish the RSP

02

Conditions studied

  • Dental Implant Failed

Keywords

  • peizosurgery , osseodensification , modified ridge splitting , dental implant
03

In context

Lead sponsor

University of Baghdad is the lead sponsor of 164 studies on the registry; 66 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patient's age ≥18 years.
  2. Absence of any medical disease that compromise wound healing.
  3. Patient with good oral hygiene.
  4. Narrow alveolar bone (3-4 mm) with minimum alveolar bone height of (12 mm).

Exclusion criteria

Exclusion criteria:

  1. Uncontrolled medically compromised patients.
  2. Heavy smokers (> 10 cigarettes per day).
  3. Patient with parafunctional habits.
  4. Local infection at implant site.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Other
    measurement of alveolar ridge width

    the surgical procedure started with envelop flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility. Measuring the width of the alveolar ridge 1 mm below the crest using bone caliber. Using piezoelectric surgery unit (Piezosurgery Ultrasonic® mectron, Italy), a horizontal crestal cut was produced along the crest of the bone. The cut depth extended into the same depth of the final dental implant to be inserted and then Versah Drills will be used in a successive manner and under copious irrigation with chilled sterile normal saline.We will measure the rate of ridge expansion by bone caliber to determine the efficacy of combining Versah drills with piezo surgery in expanding narrow alveolar bone.

    Device: measurement of alveolar ridge width

Interventions

  • Devicemeasurement of alveolar ridge width

    the surgical procedure started with envelop flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility. Measuring the width of the alveolar ridge 1 mm below the crest using bone caliber. Using piezoelectric surgery unit (Piezosurgery Ultrasonic® mectron, Italy), a horizontal crestal cut was produced along the crest of the bone. The cut depth extended into the same depth of the final dental implant to be inserted and then Versah Drills will be used in a successive manner and under copious irrigation with chilled sterile normal saline.We will measure the rate of ridge expansion by bone caliber to determine the efficacy of combining Versah drills with piezo surgery in expanding narrow alveolar bone.

06

What researchers measure

Primary outcomes

  1. expansion rate

    by digital vernier

    Time frame: immediately

  2. expansion rate

    by digital vernier

    Time frame: after 6 months

07

Study locations

1 site
  • University of Baghdad College of Dentistry
    Baghdad, 10011, Iraq
08

References and documents

Individual participant data

Plan to share: Yes — It will be mostly available on request.

Supporting information: Study protocol, Sap, Icf, Csr

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 Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06294171
Lead sponsor
University of Baghdad
Responsible party
Amjed Kadhim Tayyeh (Bachelor's dental Surgery ( B. D. S), University of Baghdad) — Principal investigator
First posted
Mar 5, 2024
Start date
Nov 15, 2022
Primary completion
May 1, 2023
Completion
Nov 1, 2023
Last update
Mar 5, 2024

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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