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Clinical Trials/NCT05390996
NCT05390996UnknownNot Applicable

Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods: A Randomized Controlled Study

University of Baghdad1 site in 1 country35 target enrollmentStarted: January 5, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
35
Locations
1
Primary Endpoint
secondary stability

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

condensation drilling technique

Active Comparator

condensation of bone (osseodensefecation technique)

Intervention: dental implant placement (Other)

conventional drilling technique

Sham Comparator

control group

Intervention: dental implant placement (Other)

Outcomes

Primary Outcomes

secondary stability

Time Frame: 12 week post surgery

Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

primary stability

Time Frame: 0 day (baseline)

Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

stability at the dip period

Time Frame: 6 week post surgery

Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Noor Abdulhakeem

Msc.student

University of Baghdad

Study Sites (1)

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