Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Edentulous Alveolar Ridge

Intervention / Treatment
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* Procedure: Densah® burs
* Procedure: Conventional Burs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dividing two groups according drill type and parallelly measured during study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Densah® bur<br>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. | Procedure: Densah® burs<br>* 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.<br>* Other names: Study group;|
| Active Comparator: Conventional bur<br>Conventional bur is the gold standard bur that used to prepare the osteotomy for dental implant. | Procedure: Conventional Burs<br>* 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.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |