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

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

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

Study Overview

• Status: Completed
• Conditions: Dental Implant Failed
• Intervention / Treatment: Device: measurement of alveolar ridge width

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10011
    • University of Baghdad College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
expansion rate	by digital vernier	immediately
expansion rate	by digital vernier	after 6 months

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: peizosurgery , osseodensification , modified ridge splitting , dental implant
• Other Study ID Numbers: Modified Alveolar Bone Cut

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be mostly available on request.
• IPD Sharing Time Frame: 11/11/2024 for 3 month
• IPD Sharing Access Criteria: I can provide data as word
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No