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CompletedNCT06957860Updated May 5, 2025

Septal Bone Expansion Using Osseodensification Versus Piezoelectric Implant Site Preparation

An interventional study of Piezotome and Densah burs in Dental Implant and Osseodensification, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-05.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Nov 2023, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

: Implant placement in the inter radicular septum is usually considered the best option for an immediate molar implant, not only in terms of correct 3D positioning, but also regarding implant survival, Osseodensification was shown to enhance implant primary stability, due to the compaction auto-grafting and the associated spring-back effect. Piezoelectric implant site preparation (PISP) has been proposed as an alternative technique to improve surgical control, safety, and bone healing response Aim of the work: To evaluate and compare stability changes using insertion torque values (ITV) and Implant Stability Quotient values (ISQ) for immediately placed implants in molar septum using Osseodensification technique and Piezoelectric implant site preparation (PISP) technique.

02

Conditions studied

  • Dental Implant
  • Osseodensification
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients with hopeless mandibular molar teeth in the posterior region in need of implant placement .
  • A fully intact facial bone wall at the extraction site.
  • Systemically healthy, received no head and neck radiation for cancer treatment.
  • Absence of periapical pathologies or suppuration at the time of installing the implants.
  • Septal bone after atraumatic extraction not less than 3 mm.

Exclusion criteria

Exclusion Criteria:

  • Systemic conditions that would prevent successful healing or implant osseointegration; examples are uncontrolled Diabetes Mellitus, metabolic bone disorders, autoimmune diseases, or Bisphosphonate therapy.
  • Heavy smoker patients.
  • Presence of preapical bone loss related to extracted tooth.
  • Patient is not indicated for immediate implant placement
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    piezoelectric group

    Other: Piezotome

  • Experimental
    osseodensification

    Other: Densah burs

Interventions

  • OtherPiezotome

    Four Intra-lift diamond tips were used for drilling the osteotomy, increasing diameters till a final diameter of 2.8 mm is reached for placement of 3.5 mm diameter and 10-12 mm length implant.

  • OtherDensah burs

    implant drilling procedures will be done using the surgical drills of the supplier kit of densah burs. Surgical drills of increasing diameters will be used till a final drill diameter of 3 mm for placement of a 3.5 mm diameter.

06

What researchers measure

Primary outcomes

  1. Change in implant stability

    The implant stability quotient (ISQ) will be measured using the Osstell device- resonance frequency analysis test at 3 months post-surgery to all the installed fixtures.

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Change in bone density

    Using CBCT

    Time frame: Baseline and 3 months

07

Study locations

1 site
  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
    Alexandria, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06957860
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Lecturer of Dental Public Health and biostatistical consultanat, Alexandria University) — Sponsor-investigator
First posted
May 5, 2025
Start date
Nov 23, 2023
Primary completion
Aug 24, 2024
Completion
Aug 24, 2024
Last update
May 5, 2025

Oversight

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

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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