Primary Stability of Immediate Implant Using Versah Versus Conventional Burs

NCT05960916 | Unknown

• 1 other identifier: 121189
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Implant Stability Quotient (ISQ)

  Changes in implant stability after 16 weeks (secondary stability) from baseline value measured immediately after implant placement (primary stability)

Study Arms (2)

Densah® bur

EXPERIMENTAL

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

Conventional bur

ACTIVE COMPARATOR

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

Procedure: Conventional Burs

Interventions

Densah® burs 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.

Also known as: Study group

Densah® bur

Conventional Burs 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.

Also known as: Control group

Conventional bur

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Mustafa Thamir Naji

Baghdad, 10013, Iraq

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hasanain A. Al-Jumaily, C.A.B.M.S

  University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Dividing two groups according drill type and parallelly measured during study

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 27, 2023
• Study Start: January 22, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)