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Clinical Trials/NCT05685576
NCT05685576CompletedNot Applicable

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

Lydia Nabil1 site in 1 country8 target enrollmentStarted: March 25, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
8
Locations
1
Primary Endpoint
The score of primary implant stability

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Patients having periodontal disease
  • •The presence of a pathological lesion in the area of ridge splitting

Arms & Interventions

Ridge splitting and osseodensification with simultaneous implant placement

Experimental

Intervention: Piezotomed ridge splitting and osseodensification (Device)

Outcomes

Primary Outcomes

The score of primary implant stability

Time Frame: 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 Outcomes

  • The width of bone gained(3 months postoperative)
  • The mean bone density around dental implants(3 months postoperative)

Investigators

Sponsor
Lydia Nabil
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Lydia Nabil

Associate Professor of Oral and Maxillofacial Surgery

University of Alexandria

Study Sites (1)

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