Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

Not Applicable

Active, not recruiting

• Conditions: Edentulous Alveolar Ridge
• Interventions: Procedure: Conventional Burs; Procedure: Densah® burs

• Registration Number: NCT05960916
• Lead Sponsor: University of Baghdad

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.

Study Timeline

• Study Start: 2022-01-22
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study First Submitted: 2023-07-02
• Study First Submitted QC: 2023-07-22
• Last Update Submitted: 2023-07-22
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional bur	Conventional Burs	Conventional bur is the gold standard bur that used to prepare the osteotomy for dental implant.
Densah® bur	Densah® burs	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.

Primary Outcome Measures

Name	Time	Method
Primary Implant Stability Quotient (ISQ)	baseline value of implant stability measured immediately after implant installation (primary stability)	immediately after implant placement the ISQ value measured by RFA device (Osstell)

Secondary Outcome Measures

Name	Time	Method
Secondary Implant Stability Quotient (ISQ)	Changes in implant stability after 16 weeks (secondary stability) from baseline value measured immediately after implant placement (primary stability)	16 weeks after implant placement, ISQ value measured by RFA device (Osstell)

Trial Locations

Locations (1)

Mustafa Thamir Naji; 🇮🇶 Baghdad, Iraq