Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

NCT ID: NCT05960916

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-22

Study Completion Date

2023-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Edentulous Alveolar Ridge

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dividing two groups according drill type and parallelly measured during study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Densah® burs

Intervention Type PROCEDURE

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 bur

Conventional bur is the gold standard bur that used to prepare the osteotomy for dental implant.

Group Type ACTIVE_COMPARATOR

Conventional Burs

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Study group Control group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mustafa Thamer Naji

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hasanain A. Al-Jumaily, C.A.B.M.S

Role: STUDY_DIRECTOR

University of Baghdad

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mustafa Thamir Naji

Baghdad, , Iraq

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iraq

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

121189

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.