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OpenTrials
Completed

NCT Number: NCT05685576

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

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

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, 21411, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piezotomed ridge splitting and osseodensification

Device

Ridge expansion using piezotomed ridge splitting and osseodensification

Primary outcomes

  1. 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

  1. The width of bone gained

    Time frame: 3 months postoperative

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

  2. The mean bone density around dental implants

    Time frame: 3 months postoperative

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

Sponsors and collaborators

Lead sponsor

Lydia Nabil

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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