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Osseodensification Versus Conventional Drilling for Implant Site Preparation

Primary Purpose

Dental Implant Failed, Jaw, Edentulous, Partially, Edentulous Alveolar Ridge

Status
Recruiting
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Osseodensification osteotomy preparation
Standardized osteotomy preparation
Sponsored by
Mohammed Bin Rashid University of Medicine and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Implant Failed focused on measuring osseointegration, bone density, osteotomy, primary stability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Dubai Dental HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osseodensification (test) group

Standard (control) group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
Implant failure rate
Implant failure rate will be assessed clinically after one year of implant restoration and annually up to three years.

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
August 27, 2023
Last Updated
September 12, 2023
Sponsor
Mohammed Bin Rashid University of Medicine and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06034067
Brief Title
Osseodensification Versus Conventional Drilling for Implant Site Preparation
Official Title
Osseodensification Versus Conventional Drilling for Implant Site Preparation: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mohammed Bin Rashid University of Medicine and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant Failed, Jaw, Edentulous, Partially, Edentulous Alveolar Ridge, Osseointegration Failure of Dental Implant
Keywords
osseointegration, bone density, osteotomy, primary stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
- Double-blinded as both the participants and outcome accessors of radiographic outcomes will be blinded to the intervention.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osseodensification (test) group
Arm Type
Experimental
Arm 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.
Arm Title
Standard (control) group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Osseodensification osteotomy preparation
Other Intervention Name(s)
Densah® burs, Versah co., USA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standardized osteotomy preparation
Other Intervention Name(s)
Straumann® Twist Drills, Straumann, Switzerland
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Implant stability quotient (ISQ values) using resonance frequency analysis
Description
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.
Time Frame
Upto 36 months
Title
Implant failure rate
Description
Implant failure rate will be assessed clinically after one year of implant restoration and annually up to three years.
Time Frame
Upto 36 months
Secondary Outcome Measure Information:
Title
Changes in peri-implant marginal bone level (in mm)
Description
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
Time Frame
Upto 36 months
Title
Descriptive evaluation of biological and technical complications associated with dental implant restorations
Description
Descriptive evaluation of biological and technical complications will be recorded during the follow-up period
Time Frame
Upto 36 months
Title
Patient postoperative experience ( visual analogue scale )
Description
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.
Time Frame
Upto 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maanas S Shah, BDS MSD CAGS
Phone
00971556102178
Email
maanas.shah@mbru.ac.ae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maanas S Shah, BDS MSD CAGS
Organizational Affiliation
Mohammed Bin Rashid University of Medicine and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dubai Dental Hospital
City
Dubai
ZIP/Postal Code
505055
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senior Director
Phone
+971505522151
Email
khawla.belhoul@ddh.ae

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8329101
Citation
Albrektsson T, Zarb GA. Current interpretations of the osseointegrated response: clinical significance. Int J Prosthodont. 1993 Mar-Apr;6(2):95-105.
Results Reference
result
PubMed Identifier
23237585
Citation
Atieh MA, Alsabeeha NH, Faggion CM Jr, Duncan WJ. The frequency of peri-implant diseases: a systematic review and meta-analysis. J Periodontol. 2013 Nov;84(11):1586-98. doi: 10.1902/jop.2012.120592. Epub 2012 Dec 13.
Results Reference
result
PubMed Identifier
17974108
Citation
Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
Results Reference
result
PubMed Identifier
19228101
Citation
Buser D, Halbritter S, Hart C, Bornstein MM, Grutter L, Chappuis V, Belser UC. Early implant placement with simultaneous guided bone regeneration following single-tooth extraction in the esthetic zone: 12-month results of a prospective study with 20 consecutive patients. J Periodontol. 2009 Jan;80(1):152-62. doi: 10.1902/jop.2009.080360.
Results Reference
result
PubMed Identifier
11168257
Citation
Buser D, von Arx T, ten Bruggenkate C, Weingart D. Basic surgical principles with ITI implants. Clin Oral Implants Res. 2000;11 Suppl 1:59-68. doi: 10.1034/j.1600-0501.2000.011s1059.x.
Results Reference
result
PubMed Identifier
29930793
Citation
Di Stefano DA, Perrotti V, Greco GB, Cappucci C, Arosio P, Piattelli A, Iezzi G. The effect of undersizing and tapping on bone to implant contact and implant primary stability: A histomorphometric study on bovine ribs. J Adv Prosthodont. 2018 Jun;10(3):227-235. doi: 10.4047/jap.2018.10.3.227. Epub 2018 Jun 12.
Results Reference
result
PubMed Identifier
19897823
Citation
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
Results Reference
result
PubMed Identifier
27741329
Citation
Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
Results Reference
result
PubMed Identifier
33671038
Citation
Inchingolo AD, Inchingolo AM, Bordea IR, Xhajanka E, Romeo DM, Romeo M, Zappone CMF, Malcangi G, Scarano A, Lorusso F, Isacco CG, Marinelli G, Contaldo M, Ballini A, Inchingolo F, Dipalma G. The Effectiveness of Osseodensification Drilling Protocol for Implant Site Osteotomy: A Systematic Review of the Literature and Meta-Analysis. Materials (Basel). 2021 Feb 28;14(5):1147. doi: 10.3390/ma14051147.
Results Reference
result
PubMed Identifier
24381734
Citation
Javed F, Ahmed HB, Crespi R, Romanos GE. Role of primary stability for successful osseointegration of dental implants: Factors of influence and evaluation. Interv Med Appl Sci. 2013 Dec;5(4):162-7. doi: 10.1556/IMAS.5.2013.4.3. Epub 2013 Dec 20.
Results Reference
result
PubMed Identifier
16672018
Citation
Lioubavina-Hack N, Lang NP, Karring T. Significance of primary stability for osseointegration of dental implants. Clin Oral Implants Res. 2006 Jun;17(3):244-50. doi: 10.1111/j.1600-0501.2005.01201.x.
Results Reference
result
PubMed Identifier
9922740
Citation
Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501.
Results Reference
result
PubMed Identifier
9693511
Citation
Sennerby L, Meredith N. Resonance frequency analysis: measuring implant stability and osseointegration. Compend Contin Educ Dent. 1998 May;19(5):493-8, 500, 502; quiz 504.
Results Reference
result
PubMed Identifier
18412573
Citation
Sennerby L, Meredith N. Implant stability measurements using resonance frequency analysis: biological and biomechanical aspects and clinical implications. Periodontol 2000. 2008;47:51-66. doi: 10.1111/j.1600-0757.2008.00267.x. No abstract available.
Results Reference
result
PubMed Identifier
26584202
Citation
Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.
Results Reference
result
PubMed Identifier
19522976
Citation
Trisi P, Perfetti G, Baldoni E, Berardi D, Colagiovanni M, Scogna G. Implant micromotion is related to peak insertion torque and bone density. Clin Oral Implants Res. 2009 May;20(5):467-71. doi: 10.1111/j.1600-0501.2008.01679.x.
Results Reference
result

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Osseodensification Versus Conventional Drilling for Implant Site Preparation

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