Osseodensification Versus Conventional Drilling for Implant Site Preparation

Dental Implant Failed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06034067
• Other study ID #: MBRU IRB-2021-61
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Mohammed Bin Rashid University of Medicine and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Arab Emirates	Dubai Dental Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed Bin Rashid University of Medicine and Health Sciences

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (16)

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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. — View 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. — View 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 conse — View 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. — View 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):22 — View 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. — View 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: 10.1 — View 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 Im — View 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. — View 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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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