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

NCT ID: NCT05685576

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2023-03-05

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.

Conditions

Alveolar Process Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ridge splitting and osseodensification with simultaneous implant placement

Group Type: EXPERIMENTAL

Piezotomed ridge splitting and osseodensification

Intervention Type: DEVICE

Ridge expansion using piezotomed ridge splitting and osseodensification

Interventions

Piezotomed ridge splitting and osseodensification

Ridge expansion using piezotomed ridge splitting and osseodensification

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lydia Nabil

OTHER

Sponsor Role: lead

Responsible Party

Lydia Nabil

Associate Professor of Oral and Maxillofacial Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dentistry

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

UAlexandriaDentSurg22

Identifier Type: -

Identifier Source: org_study_id