Osseodensification Versus Conventional Drilling for Implant Site Preparation

Mohammed Bin Rashid University of Medicine and Health Sciences

Status: Active, not recruiting

Conditions: Edentulous Alveolar Ridge; Jaw, Edentulous, Partially; Dental Implant Failed; Osseointegration Failure of Dental Implant

Treatments: Procedure: Osseodensification osteotomy preparation; Procedure: Standardized osteotomy preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT06034067

MBRU IRB-2021-61

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18 or over.
• Require replacement of an anterior or posterior single tooth with dental implant.
• Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
• Good compliance and commitment to attend follow-up review appointments.
• Willing to provide informed consent.

Exclusion criteria

• Localized / generalized periodontitis.
• Bone metabolic disease and/or taking medications that affect bone metabolism.
• Long term use of non-steroidal anti-inflammatory medications.
• History of malignancy, radiotherapy or chemotherapy.
• Pregnant or lactating women.
• Severe bruxism or parafunctional habits.
• Participants, who have controlled medical condition or smokers, will not be excluded in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Osseodensification (test) group

Experimental group

Description:

Implant site preparation will be completed using osseodensification technique where tapered multifluted burs (Densah Burs; Versah, MI, USA) will be used as per manufacturer's instructions.

Treatment:

Procedure: Osseodensification osteotomy preparation

Standard (control) group

Active Comparator group

Description:

Implant site preparation will be completed using conventional drilling protocol technique where standardized drills provided by Straumann (Straumann®, Institute Straumann AG, Basel, Switzerland)) will be used as per manufacturer's instructions.

Treatment:

Procedure: Standardized osteotomy preparation