NCT07061015

Brief Summary

different possible osseodensification techniques used to improve bone density around dental implants, using either \] osseodensifying drills, reverse drilling of conventional drills, and rotary expanders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
Last Updated

July 11, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

June 22, 2025

Last Update Submit

July 10, 2025

Conditions

Osseodensification

Outcome Measures

Primary Outcomes (3)

  • peri implant bone density

    through ROI (region of interest) to measure Grey scale on Cone beam computed tomography CBCT

    12 months

  • implant stability quotient

    ISQ (implant stability quotient) using osstell device

    12 months

  • alveolar ridge dimension changes

    with cone beam computed tomography CBCT in coronal and sagittal cuts, in millimeters mm .

    12 months

Study Arms (3)

osseodensifying burs

ACTIVE COMPARATOR

osseodensifying burs are used in reverse motion .

Procedure: osseodenification with osseodensifying burs

reverse drilling

ACTIVE COMPARATOR

using conventional implant drills in reverse motion(anti clock wise)

Procedure: reverse drilling

rotary expanders

ACTIVE COMPARATOR

using rotary expanders in clock wise motion

Procedure: rotary expanders

Interventions

osseodenification with osseodensifying bursPROCEDURE

different osseodensification techniques to be studied

osseodensifying burs
reverse drillingPROCEDURE

using the conventional drills in reverse mode

reverse drilling
rotary expandersPROCEDURE

expanders in clockwise direction

rotary expanders

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • · Adult osteoporotic female patients confirmed by CBCT grey values ranging from 290 to 420 HU, with age range 45-60 years.
  • Patients should be free from any other systemic diseases, according to ASA classifications (American society of Anesthesiologists).
  • Patients of single or multiple missing teeth in the posterior mandible.
  • A ridge width of 4mm and a height of \> 8mm above the roof of Inferior Alveolar canal.
  • No buccal concavities were present at the planned implant site

You may not qualify if:

  • · Poor oral hygiene.
  • Heavy smoker (more than 20 cigarettes /day),or alcoholic abusing patients.
  • Radiation therapy to the head and neck region, or chemotherapy in the last 6 months prior to the implant placement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta university for science and technology

Al Mansurah, Daqhlia, 35515, Egypt

Location

Study Officials

  • Mohammed MZ M Zaghlol Amer, Professor

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 11, 2025

Study Start

March 1, 2023

Primary Completion

September 10, 2024

Study Completion

January 15, 2025

Last Updated

July 11, 2025

Record last verified: 2025-06

Locations

EG(1)