Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods
1 other identifier
interventional
35
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of Osseodensification on implant stability during the healing period The objective of this study is to compare between dental implant stability after osteotomy site preparation using osseodensification technique and conventional drilling technique immediately after implant installation (primary stability) , 6 week after the insertion of implant and 12 weeks later (secondary stability)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
1 active site
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
January 5, 2022
CompletedFirst Submitted
Initial submission to the registry
May 7, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedMay 25, 2022
May 1, 2022
8 months
May 7, 2022
May 22, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
primary stability
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
0 day (baseline)
stability at the dip period
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
6 week post surgery
secondary stability
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
12 week post surgery
Study Arms (2)
condensation drilling technique
ACTIVE COMPARATORcondensation of bone (osseodensefecation technique)
conventional drilling technique
SHAM COMPARATORcontrol group
Interventions
dental implant placement by using a different drilling techniques
Eligibility Criteria
You may qualify if:
- medically fit patients ≥ 18 years of age including both genders
- alveolar ridges of sufficient vertical and horizontal dimensions
- bone density less than 850 Hounsfield units (HU) which corresponds to D3-D5 bone density according to Misch bone classification based on preoperative CBCT findings
You may not qualify if:
- Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification are not suitable for osseodensification.
- Patient with severe buccal plate undercut or concavity
- Active infection or inflammation in the implant zone
- Presence of any uncontrolled systemic diseases.
- Any patient need advance treatment such as sinus lifting and bone augmentation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baghdad University
Baghdad, Babalmatham, 00964, Iraq
Study Officials
- PRINCIPAL INVESTIGATOR
Salwan Y Bede, BDS,FIMBS
University of Bagh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Msc.student
Study Record Dates
First Submitted
May 7, 2022
First Posted
May 25, 2022
Study Start
January 5, 2022
Primary Completion
September 1, 2022
Study Completion
January 1, 2023
Last Updated
May 25, 2022
Record last verified: 2022-05