Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:28 PM
Study NCT ID:
NCT06034067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-24
First Post:
2023-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osseodensification Versus Conventional Drilling for Implant Site Preparation
Sponsor:
Mohammed Bin Rashid University of Medicine and Health Sciences
Organization:
Study Overview
Official Title:
Osseodensification Versus Conventional Drilling for Implant Site Preparation: a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A total of 34 participants, who require replacement of an anterior or posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the control group, the osteotomy site preparation will be prepared by using conventional surgical drills, while the test group site preparation will involve the use of Densah™ Burs (Versah Co., LLC., USA) as per the osseodensification protocol. In addition to evaluating implant stability, the trial will also report on implant and patient outcomes at various time points.
Detailed Description:
Osseodensification technique has demonstrated increased primary stability and increased bone mineral density around the osteotomy site. The implants placed into osseous densification osteotomies have shown significant increase in insertion and removal torque values. This technique also burnishes bone along the inner layer of the osteotomy site and create a condensed layer of autografted bone along the periphery and apex of the implant. This would, in turn, increase the bone-implant contact enhancing the insertion torque values, and thus, primary implant stability. This new technique has not only shown increased primary implant stability when compared with conventional drilling, but also, shown to have similar clinical safety to conventional methods of osteotomy site preparation. Although osseodensification has been reported to enhance the clinical outcomes of implants by increasing primary stability, its long-term effects on implant stability measurements and implant survival rates are still not clear. The purpose of the present randomized controlled trial is to evaluate the stability of implants placed in sites prepared with either conventional drilling or osseodensification and report on implant and patient outcomes at various time points.
Objectives:
The aims of the randomized controlled trial are:
* To evaluate implant stability as measured by implant stability quotient (ISQ).
* To evaluate the clinical, radiographic outcomes and implant survival rates.
* To evaluate the need for additional bone augmentation at the time of implant placement.
* To evaluate changes in peri-implant marginal bone level.
* To evaluate bone quality as estimated by clinicians during osteotomy preparation.
* To evaluate biological and technical complications during the follow-up period.
* To evaluate patient reported outcomes.
Objectives:
The aims of the randomized controlled trial are:
* To evaluate implant stability as measured by implant stability quotient (ISQ).
* To evaluate the clinical, radiographic outcomes and implant survival rates.
* To evaluate the need for additional bone augmentation at the time of implant placement.
* To evaluate changes in peri-implant marginal bone level.
* To evaluate bone quality as estimated by clinicians during osteotomy preparation.
* To evaluate biological and technical complications during the follow-up period.
* To evaluate patient reported outcomes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: