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Completed

NCT Number: NCT04609475

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

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.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osseodensification technique

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

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.

Primary outcomes

  1. Post-operative pain

    Time frame: up to 1 month

    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

  2. Implant stability

    Time frame: up to 6 months

    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.

  3. Bone density

    Time frame: up to 6 months

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

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2020
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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