Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Edentulous Alveolar Ridge
• Intervention / Treatment: Procedure: Densah® burs; Procedure: Conventional Burs

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10013
    • Mustafa Thamir Naji

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Densah® bur; 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; 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.; Other Names: Study group
Active Comparator: Conventional bur; Conventional bur is the gold standard bur that used to prepare the osteotomy for dental implant.	Procedure: 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.; Other Names: Control group

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Director: Hasanain A. Al-Jumaily, C.A.B.M.S, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: July 2, 2023
• First Submitted That Met QC Criteria: July 22, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 121189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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