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Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement

Primary Purpose

Alveolar Process Atrophy

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Piezotomed ridge splitting and osseodensification

About this trial

This is an interventional treatment trial for Alveolar Process Atrophy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with good oral hygiene Patients with long-span, narrow posterior edentulous mandibular area Age limit range [25 - 66 years] Patients who accept to participate in the study Minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal Minimum ridge thickness = 3mm at the crestal region If the patient is diabetic, should be controlled. Exclusion Criteria: Immunosuppressive/ autoimmune disease patients Patients with osteoporosis Lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle Patients with bleeding disorder disease Ridge width less than 3 mm Smokers Patients having periodontal disease The presence of a pathological lesion in the area of ridge splitting

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ridge splitting and osseodensification with simultaneous implant placement

Arm Description

Outcomes

Primary Outcome Measures

The score of primary implant stability

- Primary stability of the implants is measured using: insertion torque and resonance frequency analysis by Osstell ISQ device (Osstell ISQ, W&H, Sweden)

Secondary Outcome Measures

The width of bone gained

Width of bone gained at the crest of the ridge is measured by cone beam computed tomography in mm

The mean bone density around dental implants

The mean bone density around dental implants is measured by cone beam computed tomography in grey scale values

Full Information

NCT ID

NCT05685576

First Posted

January 4, 2023

Last Updated

May 8, 2023

Sponsor

Lydia Nabil

1. Study Identification

Unique Protocol Identification Number

NCT05685576

Brief Title

Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement

Official Title

Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement in Narrow Posterior Mandible

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

March 25, 2022 (Actual)

Primary Completion Date

March 4, 2023 (Actual)

Study Completion Date

March 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lydia Nabil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.

Detailed Description

This study is a single arm clinical trial. Patients of both genders, who are indicated for ridge splitting, were recruited from the outpatient clinic, Faculty of dentistry, Alexandria University. The PICO question: "What is the effect of piezotomed ridge splitting and osseodensification on implant placement in narrow posterior mandibular ridges?" Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry. All patients were informed about the procedure details, and each participant signed a written consent. Ridge expansion was accomplished by piezotomed ridge splitting and osseodensification. Simultaneous implant placement was done in the same procedure. Implant stability was assessed. Also, bone width gained and bone density were measured around the dental implants using cone beam computed tomography.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Process Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ridge splitting and osseodensification with simultaneous implant placement

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Piezotomed ridge splitting and osseodensification

Intervention Description

Ridge expansion using piezotomed ridge splitting and osseodensification

Primary Outcome Measure Information:

Title

The score of primary implant stability

Description

- Primary stability of the implants is measured using: insertion torque and resonance frequency analysis by Osstell ISQ device (Osstell ISQ, W&H, Sweden)

Time Frame

immediately at time of implant insertion

Secondary Outcome Measure Information:

Title

The width of bone gained

Description

Width of bone gained at the crest of the ridge is measured by cone beam computed tomography in mm

Time Frame

3 months postoperative

Title

The mean bone density around dental implants

Description

The mean bone density around dental implants is measured by cone beam computed tomography in grey scale values

Time Frame

3 months postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Faculty of Dentistry

City

Alexandria

ZIP/Postal Code

21411

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement

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