Back to results

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

Primary Purpose

Alveolar Bone Loss

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Osseodensification technique

Motor driven expanders' technique

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Endosseous implants, Osseodensification

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osseodensification technique

Motor driven expanders' technique

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Bone density

This will be assessed using cone beam computed tomography (CBCT)

Secondary Outcome Measures

Full Information

NCT ID

NCT04609475

First Posted

October 24, 2020

Last Updated

October 24, 2020

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04609475

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

October 14, 2019 (Actual)

Primary Completion Date

September 4, 2020 (Actual)

Study Completion Date

October 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Loss

Keywords

Endosseous implants, Osseodensification

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Osseodensification technique

Arm Type

Experimental

Arm Title

Motor driven expanders' technique

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Osseodensification technique

Intervention Description

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

Intervention Name(s)

Motor driven expanders' technique

Intervention Description

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.

Primary Outcome Measure Information:

Title

Post-operative pain

Description

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

Time Frame

up to 1 month

Title

Implant stability

Description

Time Frame

up to 6 months

Title

Bone density

Description

This will be assessed using cone beam computed tomography (CBCT)

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaimaa A Abdou, BDS

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Magued H Fahmy, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ahmed O Sweedan, PhD

Organizational Affiliation

Faculty of Dentistry, Alexandria University, Egypt

Official's Role

Study Director

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21512

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

22117707

Citation

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.

Results Reference

background

PubMed Identifier

25615915

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.

Results Reference

background

PubMed Identifier

19885432

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.

Results Reference

background

PubMed Identifier

15142097

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

Results Reference

background

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

background

PubMed Identifier

17356368

Citation

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.

Results Reference

background

PubMed Identifier

24583140

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.

Results Reference

background

PubMed Identifier

19674646

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs