Back to resultsPrimary Stability of Immediate Implant Using Versah Versus Conventional Burs
Primary Purpose
Edentulous Alveolar Ridge
Status
Active
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Densah® burs
Conventional Burs
Sponsored by
About this trial
This is an interventional supportive care trial for Edentulous Alveolar Ridge
Eligibility Criteria
Inclusion Criteria: Healthy and medically fit patients Patients age ≥18 years for both gender Apical bone ≥ 2mm from vertical structure showed in x-rays. Patient has tooth or teeth with single root anterior and\or posterior area cannot restored by another dental treatment procedure. Exclusion Criteria: Patient with active periodontal disease. Pregnancy or lactation. A local or systemic disorder that is contraindicated for the minor surgical procedure and may affect healing process. Any irradiation in head and neck area. Heavy smoking habit.
Sites / Locations
- Mustafa Thamir Naji
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Densah® bur
Conventional bur
Arm Description
Densah is a bur that used for drilling of the alveolar ridge that have low bone density, narrow alveolar ridge, and sinus lifting procedure in dental implant preparation technique.
Conventional bur is the gold standard bur that used to prepare the osteotomy for dental implant.
Outcomes
Primary Outcome Measures
Primary Implant Stability Quotient (ISQ)
immediately after implant placement the ISQ value measured by RFA device (Osstell)
Secondary Outcome Measures
Secondary Implant Stability Quotient (ISQ)
16 weeks after implant placement, ISQ value measured by RFA device (Osstell)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05960916
Brief Title
Primary Stability of Immediate Implant Using Versah Versus Conventional Burs
Official Title
Primary Stability of Immediate Dental Implant Using Osseodensification and Conventional Burs (A Randomized a Clinical Comparative Prospective Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed as a Prospective Randomized Clinical Trail, Evaluate the effect of osseodensification technique on primary stability in comparison to the conventional drilling technique in immediate single fresh extraction sockets.
Detailed Description
In this study, 30 dental implants inserted immediately after tooth extraction (not a multi-rooted tooth) as a two groups according to bur drill technique and measure the primary stability by osstell devise based on resonance frequency analysis (RFA) value which is scaled from 1-100, after 16 weeks measuring the secondary stability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Dividing two groups according drill type and parallelly measured during study
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Densah® bur
Arm Type
Experimental
Arm Description
Densah is a bur that used for drilling of the alveolar ridge that have low bone density, narrow alveolar ridge, and sinus lifting procedure in dental implant preparation technique.
Arm Title
Conventional bur
Arm Type
Active Comparator
Arm Description
Conventional bur is the gold standard bur that used to prepare the osteotomy for dental implant.
Intervention Type
Procedure
Intervention Name(s)
Densah® burs
Other Intervention Name(s)
Study group
Intervention Description
Osseodensification is a non-excavating implant site preparation technique, it creates a densified layer of surrounding bone through compaction autografting while simultaneously plastically expanding the bony ridge at the same time facilitating for placement of large diameter implants and also avoiding fenestration and dehiscence defects.
Intervention Type
Procedure
Intervention Name(s)
Conventional Burs
Other Intervention Name(s)
Control group
Intervention Description
Conventional burs is the gold standard that used to prepare the osteotomy site by drilling of the bone and creating a bed for implant placement, it is used according to the manufacturer instructions.
Primary Outcome Measure Information:
Title
Primary Implant Stability Quotient (ISQ)
Description
immediately after implant placement the ISQ value measured by RFA device (Osstell)
Time Frame
baseline value of implant stability measured immediately after implant installation (primary stability)
Secondary Outcome Measure Information:
Title
Secondary Implant Stability Quotient (ISQ)
Description
16 weeks after implant placement, ISQ value measured by RFA device (Osstell)
Time Frame
Changes in implant stability after 16 weeks (secondary stability) from baseline value measured immediately after implant placement (primary stability)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy and medically fit patients
Patients age ≥18 years for both gender
Apical bone ≥ 2mm from vertical structure showed in x-rays.
Patient has tooth or teeth with single root anterior and\or posterior area cannot
restored by another dental treatment procedure.
Exclusion Criteria:
Patient with active periodontal disease.
Pregnancy or lactation.
A local or systemic disorder that is contraindicated for the minor surgical procedure
and may affect healing process.
Any irradiation in head and neck area.
Heavy smoking habit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasanain A. Al-Jumaily, C.A.B.M.S
Organizational Affiliation
University of Baghdad
Official's Role
Study Director
Facility Information:
Facility Name
Mustafa Thamir Naji
City
Baghdad
ZIP/Postal Code
10013
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Primary Stability of Immediate Implant Using Versah Versus Conventional Burs
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