Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement

Alveolar Bone Loss Clinical Trial

Official title:

Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609475
• Other study ID #: Osseodensification technique
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: October 4, 2020

Study information

• Verified date: October 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to compare and measure the amount of bone density and ridge width gained with motor driven expanders and densifying burs with simultaneous dental implant placement.

Description:

Seven patients were treated by the osseodensification technique and another seven were treated by the motor-driven expanders' technique with simultaneous implant placement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Patients requiring implant placement in the anterior maxilla until the premolar region.
• Patients are medically fit.
• The width of the deficient maxillary alveolar ridge not less than 3mm.
• Patients willing and fully capable to comply with the study protocol.

Exclusion Criteria:

• Atrophic ridge (2 mm or less) with no interposition of cancellous bone between the buccal and palatal plates.
• Uncontrolled metabolic disease (e.g. uncontrolled diabetes).
• Heavy smokers (>15 cigarettes/day).
• Acute oral infections.
• Untreated periodontal disease.
• Poor oral hygiene.
• Pregnant or breastfeeding patient.
• A history of radiotherapy to the head and neck region or treatment with bisphosphonates.
• Female patients using oral contraceptive pills.
• Presence of oral parafunctional habits.
• Surgical site needs to be grafted.

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Procedure:
• Osseodensification technique
Implant bed preparation will be performed according to the manufacturer's guidelines, densifying burs (Densah® Burs) will be used sequentially in densifying mode (counterclockwise drill speed 800-1500 rpm with copious irrigation) to achieve the planned osteotomy diameter and desired ridge expansion. The implant will be then placed in the prepared osteotomy
• Motor driven expanders' technique
The technique consisted of preparing the implant bed by progressively increasing the size of the osteotomes until the desired expansion will be achieved. At the planned implant site, a pilot drill 1000 rpm with irrigation until the desired length, then expansion with the series of ridge spreaders and finally using the final drill. The implant will be then placed in the prepared osteotomy.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

Alghamdi H, Anand PS, Anil S. Undersized implant site preparation to enhance primary implant stability in poor bone density: a prospective clinical study. J Oral Maxillofac Surg. 2011 Dec;69(12):e506-12. doi: 10.1016/j.joms.2011.08.007. — View Citation

Bornstein MM, Cionca N, Mombelli A. Systemic conditions and treatments as risks for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:12-27. Review. — View Citation

Boustany CM, Reed H, Cunningham G, Richards M, Kanawati A. Effect of a modified stepped osteotomy on the primary stability of dental implants in low-density bone: a cadaver study. Int J Oral Maxillofac Implants. 2015 Jan-Feb;30(1):48-55. doi: 10.11607/jomi.3720. — View Citation

Hatano N, Shimizu Y, Ooya K. A clinical long-term radiographic evaluation of graft height changes after maxillary sinus floor augmentation with a 2:1 autogenous bone/xenograft mixture and simultaneous placement of dental implants. Clin Oral Implants Res. 2004 Jun;15(3):339-45. — 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: 10.11607/jomi.4817. Epub 2016 Oct 14. — View Citation

Hwang D, Wang HL. Medical contraindications to implant therapy: Part II: Relative contraindications. Implant Dent. 2007 Mar;16(1):13-23. — View Citation

Jimbo R, Tovar N, Marin C, Teixeira HS, Anchieta RB, Silveira LM, Janal MN, Shibli JA, Coelho PG. The impact of a modified cutting flute implant design on osseointegration. Int J Oral Maxillofac Surg. 2014 Jul;43(7):883-8. doi: 10.1016/j.ijom.2014.01.016. Epub 2014 Feb 28. — View Citation

Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Pain was assessed using a 10-point Visual Analogue Scale (VAS). The lower values indicates lower pain levels and higher values indicates higher pain levels	up to 1 month
Primary	Implant stability	Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded.	up to 6 months
Primary	Bone density	This will be assessed using cone beam computed tomography (CBCT)	up to 6 months