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RecruitingNCT06677125Updated Nov 6, 2024

Magnetic Mallet and Densah Bur for Crestal Sinus Left

An interventional study of Electrical Mallet and Densah bur in Maxillary Sinus Left, sponsored by Hams Hamed Abdelrahman. Recruiting at 1 site in Egypt. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-06.

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

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Jan 2024, registered Nov 2024).
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

Background: Implant placement in the posterior maxilla is problematic procedure, not only due to inferior properties of bone but also due to loss of vertical bone height, which happens after extraction of posterior teeth. When the required additional height is few millimeters, indirect transcrestal sinus lifting is recommended. Aim: The aim of this study is to evaluate Densah bur versus Magnetic mallet in transcrestal sinus lifting procedure in edentulous molar and premolar maxillary region.

02

Conditions studied

  • Maxillary Sinus Left
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 111 studies on the registry; 9 are open to participants now.

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

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient seeking replacement of missing maxillary posterior teeth by dental implant procedure.
  • Residual bone height is (5-7) mm measured from crestal bone to sinus floor.
  • Both genders.
  • Good general health;
  • Good oral hygiene.

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled Diabetes.
  • Coagulation disorders.
  • Immunological disorders.
  • Previous radiation of the head and neck region.
  • Presence of chronic systemic diseases;
  • Presence of acute or chronic sinus problems;
  • Alcohol or drug abuse;
  • Heavy smokers.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Test Group

    Procedure: Electrical Mallet

  • Active comparator
    Control Group

    Procedure: Densah bur

Interventions

  • ProcedureElectrical Mallet

    The osteotome will be directly attached and pushed by magnetic mallet and a shock wave will be pushed on their tip. The electrical mallet will be imparted to osteotomes a longitudinal movement along a central axis moving up and down toward pilot bone hole providing a driving mechanism of longitudinal movements. Then the sinus lift instruments (Sweden and Martina) will be used to slowly lift the sinus. After that implant will be placed with the help of implant drilling device.

  • ProcedureDensah bur

    The implant motor will be adjusted on reverse-densifying mode with 800 to 1200 rpm. According to the desired implant dimension, it will be started with the smallest densah bur. The first densah bur will advanced in densifying mode with bouncing motion in and out movement with copious irrigation until.

06

What researchers measure

Primary outcomes

  1. Change in pain socres

    pain will be examined using visual analogue scale (VAS) 0 means no pain 10 means extreme pain

    Time frame: 3rd day, 1 week and 10 days

  2. change in implant stability

    will be measured by the Resonance Frequency Analysis using osstel

    Time frame: baseline and 4 months

Secondary outcomes

  1. change in implant protrusion length

    Immediate post- operative CBCT (T1) will be done to measure the implant protrusion length (IPL) which is the length of the implant extending into the maxillary sinus.

    Time frame: baseline and 4 months

  2. change in bone density

    it will be measured by CBCT

    Time frame: baseline and 4 months

  3. change in prescence of complications

    patients will be followed up to assess the occurence of any clincial complications

    Time frame: 3rd day, 1 week and 10 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2024
First posted
Nov 6, 2024
StartActual
Jan 1, 2024
Primary completionEst.
Jan 30, 2025
CompletionEst.
Jan 30, 2025
Last update
Nov 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06677125
Responsible party
Hams Hamed Abdelrahman (Assistant Lecturer of Dental Public Health and biostatistical consultanat, Alexandria University) — Sponsor-investigator
First posted
Nov 6, 2024
Start date
Jan 1, 2024
Primary completion
Jan 30, 2025 (estimated)
Completion
Jan 30, 2025 (estimated)
Last update
Nov 6, 2024

Study contacts

Mohamed Abdelbaset, BDS
Contact
mohabdelbaset96@gmail.com
01017900706

Oversight

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

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