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

NCT ID: NCT04609475

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-10-04

Brief Summary

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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.

Detailed Description

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

Conditions

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Alveolar Bone Loss

Keywords

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Endosseous implants Osseodensification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Osseodensification technique

Group Type EXPERIMENTAL

Osseodensification technique

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

Motor driven expanders' technique

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shaimaa A Abdou, BDS

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Magued H Fahmy, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Ahmed O Sweedan, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 22117707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25615915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19885432 (View on PubMed)

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. doi: 10.1111/j.1600-0501.2004.00996.x.

Reference Type BACKGROUND
PMID: 15142097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27741329 (View on PubMed)

Hwang D, Wang HL. Medical contraindications to implant therapy: Part II: Relative contraindications. Implant Dent. 2007 Mar;16(1):13-23. doi: 10.1097/ID.0b013e31803276c8.

Reference Type BACKGROUND
PMID: 17356368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24583140 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19674646 (View on PubMed)

Other Identifiers

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Osseodensification technique

Identifier Type: -

Identifier Source: org_study_id