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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06294171
Other study ID # Modified Alveolar Bone Cut
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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