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CompletedNCT05685576Updated May 9, 2023

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

An interventional study of Piezotomed ridge splitting and osseodensification in Alveolar Process Atrophy, sponsored by Lydia Nabil. Completed at 1 site in Egypt. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Lydia Nabil · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2022, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
25 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Alveolar Process Atrophy

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03

In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's enrollment of 8 is below the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Lydia Nabil is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Ridge splitting and osseodensification with simultaneous implant placement

    Device: Piezotomed ridge splitting and osseodensification

Interventions

  • DevicePiezotomed ridge splitting and osseodensification

    Ridge expansion using piezotomed ridge splitting and osseodensification

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: immediately at time of implant insertion

Secondary outcomes

  1. The width of bone gained

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

    Time frame: 3 months postoperative

  2. 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

    Time frame: 3 months postoperative

07

Study locations

1 site
  • Faculty of Dentistry
    Alexandria, 21411, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05685576
Lead sponsor
Lydia Nabil
Responsible party
Lydia Nabil (Associate Professor of Oral and Maxillofacial Surgery, University of Alexandria) — Sponsor-investigator
First posted
Jan 17, 2023
Start date
Mar 25, 2022
Primary completion
Mar 4, 2023
Completion
Mar 5, 2023
Last update
May 9, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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