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

Dental Implant Failed Clinical Trial

Official title:

Efficacy of Modified Piezosurgery Alveolar Bone Cut With Osseodensification Drills in Expanding Narrow Alveolar Bone (Randomized Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06294171
• Other study ID #: Modified Alveolar Bone Cut
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2024
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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:

1. Uncontrolled medically compromised patients.

2. Heavy smokers (> 10 cigarettes per day).

3. Patient with parafunctional habits.

4. Local infection at implant site.

Related Conditions & MeSH terms

• Dental Implant Failed

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Iraq	University of Baghdad College of Dentistry	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expansion rate	by digital vernier	immediately
Primary	expansion rate	by digital vernier	after 6 months