Osseodensification Versus Conventional Drilling for Implant Site Preparation

NCT06034067 | Active Not Recruiting DMC

• 1 other identifier: MBRU IRB-2021-61
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

osseointegration; bone density; osteotomy; primary stability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Changes in peri-implant marginal bone level (in mm)

  Upto 36 months

• Descriptive evaluation of biological and technical complications associated with dental implant restorations

  Upto 36 months

• Patient postoperative experience ( visual analogue scale )

  Upto 10 days

Study Arms (2)

Osseodensification (test) group

EXPERIMENTAL

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

Standard (control) group

ACTIVE COMPARATOR

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

Interventions

Osseodensification osteotomy preparation PROCEDURE

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.

Also known as: Densah® burs, Versah co., USA

Osseodensification (test) group

Standardized osteotomy preparation PROCEDURE

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.

Also known as: Straumann® Twist Drills, Straumann, Switzerland

Standard (control) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Study Sites (1)

Dubai Dental Hospital

Dubai, 505055, United Arab Emirates

Location

Related Publications (16)

• Albrektsson T, Zarb GA. Current interpretations of the osseointegrated response: clinical significance. Int J Prosthodont. 1993 Mar-Apr;6(2):95-105.

  PMID: 8329101 BACKGROUND

• 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.

  PMID: 23237585 BACKGROUND

• 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.

  PMID: 17974108 BACKGROUND

• 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.

  PMID: 19228101 BACKGROUND

• 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.

  PMID: 11168257 BACKGROUND

• 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.

  PMID: 29930793 BACKGROUND

• 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.

  PMID: 19897823 BACKGROUND

• 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.

  PMID: 27741329 BACKGROUND

• 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.

  PMID: 33671038 BACKGROUND

• 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.

  PMID: 24381734 BACKGROUND

• 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.

  PMID: 16672018 BACKGROUND

• Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501.

  PMID: 9922740 BACKGROUND

• 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.

  PMID: 9693511 BACKGROUND

• 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.

  PMID: 18412573 BACKGROUND

• 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.

  PMID: 26584202 BACKGROUND

• 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.

  PMID: 19522976 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Maanas S Shah, BDS MSD CAGS

  Mohammed Bin Rashid University of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: \- Double-blinded as both the participants and outcome accessors of radiographic outcomes will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: * 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.

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 13, 2023
• Study Start: October 31, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)