NCT06034067

Osseodensification Versus Conventional Drilling for Implant Site Preparation

Osseodensification Versus Conventional Drilling for Implant Site Preparation: a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Implant Failed
• Jaw, Edentulous, Partially
• Edentulous Alveolar Ridge
• Osseointegration Failure of Dental Implant

Interventions

Type	Name	Description
PROCEDURE	Osseodensification osteotomy preparation	The implant site will be prepared by raising a mucoperiosteal flap. Implant osteotomy will be prepared by using osseodensification technique using Versah burs and a dental implant will be placed. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.
PROCEDURE	Standardized osteotomy preparation	The implant site will be prepared by raising a mucoperiosteal flap. Implant osteotomy will be prepared by using either conventional surgical drills provided by Straumann implant systems and a dental implant will be placed. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.

Timeline

• Start date: 2023-10-31
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2023-09-13
• Last updated: 2025-04-24

Locations

1 site across 1 country: United Arab Emirates