Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods

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

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 Overview

• Status: Active, not recruiting
• Conditions: Dental Implant Stability
• Intervention / Treatment: Other: dental implant placement

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Babalmatham
    • Baghdad, Babalmatham, Iraq, 00964
      • Baghdad University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. medically fit patients ≥ 18 years of age including both genders
2. alveolar ridges of sufficient vertical and horizontal dimensions
3. 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:

1. Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification are not suitable for osseodensification.
2. Patient with severe buccal plate undercut or concavity
3. Active infection or inflammation in the implant zone
4. Presence of any uncontrolled systemic diseases.
5. Any patient need advance treatment such as sinus lifting and bone augmentation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: condensation drilling technique; condensation of bone (osseodensefecation technique)	Other: dental implant placement; dental implant placement by using a different drilling techniques
SHAM_COMPARATOR: conventional drilling technique; control group	Other: dental implant placement; dental implant placement by using a different drilling techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Salwan Y Bede, BDS,FIMBS, University of Bagh

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2022
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: May 7, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (ACTUAL): May 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: dental implant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No