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

Not Applicable

Completed

• Conditions: Alveolar Process Atrophy
• Interventions: Device: Piezotomed ridge splitting and osseodensification

• Registration Number: NCT05685576
• Lead Sponsor: Lydia Nabil

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.

Study Timeline

• Study Start: 2022-03-25
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-17
• Primary Completion: 2023-03-04
• Study Completion: 2023-03-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ridge splitting and osseodensification with simultaneous implant placement	Piezotomed ridge splitting and osseodensification	-

Primary Outcome Measures

Name	Time	Method
The score of primary implant stability	immediately at time of implant insertion	- 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

Name	Time	Method
The width of bone gained	3 months postoperative	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	3 months postoperative	The mean bone density around dental implants is measured by cone beam computed tomography in grey scale values

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt