NCT04609475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 24, 2020

Last Update Submit

October 24, 2020

Conditions

Alveolar Bone Loss

Keywords

Endosseous implantsOsseodensification

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Bone density

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

    up to 6 months

Study Arms (2)

Osseodensification technique

EXPERIMENTAL
Procedure: Osseodensification technique

Motor driven expanders' technique

ACTIVE COMPARATOR
Procedure: Motor driven expanders' technique

Interventions

Osseodensification techniquePROCEDURE

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

Osseodensification technique
Motor driven expanders' techniquePROCEDURE

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.

Motor driven expanders' technique

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related 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.

    PMID: 22117707BACKGROUND

  • 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.

    PMID: 25615915BACKGROUND

  • 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.

    PMID: 19885432BACKGROUND

  • 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.

    PMID: 15142097BACKGROUND

  • 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: 27741329BACKGROUND

  • 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.

    PMID: 17356368BACKGROUND

  • 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.

    PMID: 24583140BACKGROUND

  • 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.

    PMID: 19674646BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Shaimaa A Abdou, BDS

    Faculty of Dentistry, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR

  • Magued H Fahmy, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY DIRECTOR

  • Ahmed O Sweedan, PhD

    Faculty of Dentistry, Alexandria University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Dental Public Health

Study Record Dates

First Submitted

October 24, 2020

First Posted

October 30, 2020

Study Start

October 14, 2019

Primary Completion

September 4, 2020

Study Completion

October 4, 2020

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

EG(1)