Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

Edentulous Alveolar Ridge Clinical Trial

Official title:

Primary Stability of Immediate Dental Implant Using Osseodensification and Conventional Burs (A Randomized a Clinical Comparative Prospective Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05960916
• Other study ID #: 121189
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 22, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: July 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Procedure:
• Densah® burs
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.
• Conventional Burs
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.

Locations

Country	Name	City	State
Iraq	Mustafa Thamir Naji	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Implant Stability Quotient (ISQ)	immediately after implant placement the ISQ value measured by RFA device (Osstell)	baseline value of implant stability measured immediately after implant installation (primary stability)
Secondary	Secondary Implant Stability Quotient (ISQ)	16 weeks after implant placement, ISQ value measured by RFA device (Osstell)	Changes in implant stability after 16 weeks (secondary stability) from baseline value measured immediately after implant placement (primary stability)