Osseodensification Versus Conventional Drilling for Implant Site Preparation

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Osseodensification osteotomy preparation
* Procedure: Standardized osteotomy preparation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, in which participants will be recruited and then followed up throughout a specified period of time. Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups. Double-blinded as both the participants and outcome accessors of radiographic outcomes will be blinded to the intervention.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osseodensification (test) group<br>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. | Procedure: Osseodensification osteotomy preparation<br>* 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.<br>* Other names: Densah® burs, Versah co., USA;|
| Active Comparator: Standard (control) group<br>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. | Procedure: Standardized osteotomy preparation<br>* 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.<br>* Other names: Straumann® Twist Drills, Straumann, Switzerland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Implant stability quotient (ISQ values) using resonance frequency analysis | Resonance frequency analysis (RFA) will be used to determine stability (the level of osseointegration) in dental implants. The stability will be presented as an implant stability quotient (ISQ) value. The measurements will be recorded at time of implant placement, delivery of implant restoration (baseline), one year of implant restoration and annually up to three years using resonance frequency analysis. | Upto 36 months | 
| Implant failure rate | Implant failure rate will be assessed clinically after one year of implant restoration and annually up to three years. | Upto 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in peri-implant marginal bone level (in mm) | Changes in peri-implant marginal bone level will be assessed at implant placement, delivery of implant restoration (baseline), one year of implant restoration and annually up to three years using standardized peri-apical radiograph. The changes in peri-implant marginal bone levels will be recorded in millimeters | Upto 36 months | 
| Descriptive evaluation of biological and technical complications associated with dental implant restorations | Descriptive evaluation of biological and technical complications will be recorded during the follow-up period | Upto 36 months | 
| Patient postoperative experience ( visual analogue scale ) | Patient postoperative experience will be assessed using visual analogue scale during the first week following implant placement; the scale consists of a 10cm line, with end points representing 0 ('no pain') and 10 ('unbearable/worst pain'). The participant will be asked to place a mark on he line indicating the level of pain that he/she experienced. | Upto 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osseointegration, bone density, osteotomy, primary stability