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

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

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

Study Overview

• Status: Completed
• Conditions: Alveolar Process Atrophy
• Intervention / Treatment: Device: Piezotomed ridge splitting and osseodensification

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21411
    • Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ridge splitting and osseodensification with simultaneous implant placement	Device: Piezotomed ridge splitting and osseodensification; Ridge expansion using piezotomed ridge splitting and osseodensification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	immediately at time of implant insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The width of bone gained	Width of bone gained at the crest of the ridge is measured by cone beam computed tomography in mm	3 months postoperative
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	3 months postoperative

Collaborators and Investigators

• Sponsor: Lydia Nabil

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Actual): March 4, 2023
• Study Completion (Actual): March 5, 2023

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: UAlexandriaDentSurg22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No