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

NCT06294171 | Completed DMC

• 1 other identifier: Modified Alveolar Bone Cut
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Implant Failed

Keywords

peizosurgery , osseodensification , modified ridge splitting , dental implant

Outcome Measures

Primary Outcomes (2)

• expansion rate

  by digital vernier

  immediately

• expansion rate

  by digital vernier

  after 6 months

Study Arms (1)

measurement of alveolar ridge width

OTHER

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

measurement of alveolar ridge width DEVICE

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.

measurement of alveolar ridge width

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Uncontrolled medically compromised patients.
• Heavy smokers (\> 10 cigarettes per day).
• Patient with parafunctional habits.
• Local infection at implant site.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad College of Dentistry

Baghdad, 10011, Iraq

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor's dental Surgery ( B. D. S)

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: November 15, 2022
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 11/11/2024 for 3 month
• Access Criteria: I can provide data as word

Locations

IR (1)