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CompletedNCT04589806Updated Oct 19, 2020

Change in Mandibular Bone Width Using Two Stages Splitting Approach

An interventional study of 2-stage ridge splitting in Narrow Mandibular Ridge, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

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

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled May 2018, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Alveolar ridge splitting technique is a commonly used procedure for horizontal ridge augmentation of narrow ridges to allow placement of implants. However, the commonly used one-stage technique can cause malfracture and subsequent necrosis of the fractured part.

Read the detailed description

Twelve patients were selected randomly having posterior mandibular narrow edentulous ridge. The sample were selected to match a list of inclusion and exclusion criteria. In the first stage, all patients will underwent a mandibular ridge splitting technique using piezotomes. In the second stage, ridge expansion and implants were placed with only envelope flap. Assessment were included measurement of the buccal and lingual bone surrounding the implants and amount of increase in the bone width from the cone beam computed tomography.

02

Conditions studied

  • Narrow Mandibular Ridge
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 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients aged 18-60 years old with no gender predilection.
  • Patients presenting with posterior mandibular (premolar-molar area) narrow alveolar ridge
  • that requires dental implantation.
  • Minimum bone width of 3 mm
  • Minimum bone height of 10 mm
  • Proper inter-occlusal space

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled diabetes.
  • Heavy smokers.
  • Current chemotherapy or radiotherapy.
  • Alcohol or drug abuse.
  • Pregnant women.
  • Active infection.
  • Inter-occlusal space not less than 7-8 mm.
  • Parafunctional habits.
05

Study design

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

Study arms

  • Experimental
    2-stage ridge splitting with simultaneous implant placement

    Procedure: 2-stage ridge splitting

Interventions

  • Procedure2-stage ridge splitting

    two-stage alveolar ridge splitting technique using piezoelectric device with simultaneous implant placement in order to treat narrow posterior mandibular ridges avoiding the risks of malfracture and necrosis of the split part

06

What researchers measure

Primary outcomes

  1. change in the width of the alveolar bone

    using CBCT the width were measured

    Time frame: at the 1st week and the 4th month

  2. Bone density

    using CBCT the bone width were measured

    Time frame: at the 4th week

07

Study locations

1 site
  • Alexandria Faculty of Dentistry
    Alexandria, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04589806
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Oct 19, 2020
Start date
May 1, 2018
Primary completion
Dec 21, 2019
Completion
Dec 21, 2019
Last update
Oct 19, 2020

Study contacts

Ahmed M Eid, BDS
principal investigator · Researcher

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 Oct 2020. You cannot join it, but the record below documents what was studied.

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