NCT06590753

Brief Summary

The present study will be performed to : evaluate the effect of two implant placement systems )conventional method and osseodensification method) radiographically on bone density and bone height surrounding the implant by using CBCT and clinically by probing depth and gingival index.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

May 23, 2023

Last Update Submit

September 10, 2024

Conditions

Implant Site Reaction

Keywords

implantBone densityBone height

Outcome Measures

Primary Outcomes (2)

  • bone height

    CBCT Measurements

    zero, 6, 12 months

  • bone density

    CBCT Measurements

    zero, 6, 12 months

Study Arms (2)

conventional

ACTIVE COMPARATOR

One will be placed using the conventional drill method site preparation technique on one side of the mandible

Device: osseodensification bur

osseodensification

EXPERIMENTAL

One will be placed using osseodensification (no cutting) implant site preparation technique on the other side.

Device: osseodensification bur

Interventions

osseodensification burDEVICE

osseodensification bur

conventionalosseodensification

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients will have edentulous.
  • Patient's age ranges from 55-65 years.
  • All patients should be free from any systemic disease such as bone diseases or debilitating diseases.
  • Patient's residual ridge should be covered with firm mucosa free from any signs of inflammation, ulceration, or flabby tissue.
  • Patients should have good oral hygiene.

You may not qualify if:

  • Uncooperative patients will be excluded .
  • Patient with parafunctional habits (bruxism, clenching)
  • Patient with xerostomia or excessive salivation.
  • Patient with TMJ disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azhar university (Grils)

Cairo, Egypt

RECRUITING

Central Study Contacts

Mai Ahmed, Msc

CONTACT

+201147620530mai.ahmed4417@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 23, 2023

First Posted

September 19, 2024

Study Start

December 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)