Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

Sponsor

University of Baghdad (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05960916

Collaborator

(none)

Enrollment

Location

Arms

18.3

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Edentulous Alveolar Ridge	Procedure: Densah® burs Procedure: Conventional Burs	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Dividing two groups according drill type and parallelly measured during studyDividing two groups according drill type and parallelly measured during study

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 22, 2022

Actual Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mustafa Thamir Naji	Baghdad		Iraq	10013

Sponsors and Collaborators

University of Baghdad

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mustafa Thamer Naji, Principal Investigator, University of Baghdad

ClinicalTrials.gov Identifier:

NCT05960916

Other Study ID Numbers:

121189

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mouth, Edentulous

Study Results

No Results Posted as of Jul 27, 2023