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Completed

NCT Number: NCT06667778

Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region

Dental implants supported restorations have been widely accepted as one of the treatment modalities to replace missing teeth and to restore human masticatory function. Successful osseointegration from the clinical standpoint is a measured by implant stability, which occurs after implant integration. Osseodensification is a bio-mechanical site preparation technique. It utilizes a multi-fluted densifying bur technology that creates and expands a pilot hole without excavating significant amounts of bone tissue through a unique, highly controllable, fast, and efficient procedure with minimal heat elevation.

Aim of the study: Is to evaluate and compare the efficacy of using osseodensification compared to conventional bone expansion in implant stability and ridge expansion.

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Key information

Conditions

Dental Implant Bone Expantion

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Missing maxillary anterior tooth, having moderate horizontal ridge defect in which the alveolar ridge width is( 3-4) mm, and its height is not less than 10 mm.
  • Presence of adequate keratinized mucosa.
  • Patients with good oral hygiene.
  • Patients are free from any systemic diseases that might affect healing.
  • Presence of adequate inter-occlusal and mesiodistal space that permits placement of fixed prosthesis.

Exclusion criteria

  • Heavy smokers and bad oral hygiene patients.
  • Medically compromised patients that affecting placement of implant.
  • Alcohol or drug abuse.
  • Pregnant women.
  • Patients suffering from osteoporosis.
  • Current chemotherapy or radiotherapy.

Treatment and study plan

Osseodesification densah burs

Device

Drill no. VT1525 (2mm) of densah burs will be used first in counter clockwise (in the osteotomy site).

Then drill no. VT2535 (3mm) of densah burs will be used in counter clockwise to put 3.5mm implant diameter.

Microdent

Device

No. 1 Microdent expander will be placed and screwed slowely (to avoid heat generation) into the osteotomy site till reaching the full desired length.

N0. 2 microdent expander will be placed and screwed into the osteotomy site as the same step.

Then no. 3 Microdent expander will be inserted for placing 3.5mm implant diameter

Other names: Conventional manual bone expanders

Primary outcomes

  1. Change in implant stability

    Time frame: Baseline and 16 weeks

    Implant stability will be measured using the Ostell device.

Secondary outcomes

  1. Change in bone density

    Time frame: Baseline and 16 weeks

    The patients will be examined radiographically using CBCT

  2. Change in ridge expansion

    Time frame: Baseline and 16 weeks

    The patients will be examined radiographically using CBCT

  3. Change in bone loss

    Time frame: Baseline and 16 weeks

    The patients will be examined radiographically using CBCT

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Effectiveness of Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region (a Randomized Controlled Clinical Trial)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

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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