NCT06667778

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

January 12, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

October 30, 2024

Last Update Submit

October 30, 2024

Conditions

Dental ImplantBone Expantion

Outcome Measures

Primary Outcomes (1)

  • Change in implant stability

    Implant stability will be measured using the Ostell device.

    Baseline and 16 weeks

Secondary Outcomes (3)

  • Change in bone density

    Baseline and 16 weeks

  • Change in ridge expansion

    Baseline and 16 weeks

  • Change in bone loss

    Baseline and 16 weeks

Study Arms (2)

Study group

EXPERIMENTAL
Device: Osseodesification densah burs

Control group

ACTIVE COMPARATOR
Device: Microdent

Interventions

Osseodesification densah bursDEVICE

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.

Study group
MicrodentDEVICE

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

Also known as: Conventional manual bone expanders
Control group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Alexandria, Egypt

Location

Related Publications (1)

  • Hammouda MA, Lotfy ME, Anwar SK. Effectiveness of osseodensification in enhancing implant stability and ridge expansion in esthetic zone: a randomized controlled clinical trial. Odontology. 2026 Jan 6. doi: 10.1007/s10266-025-01284-1. Online ahead of print.

    PMID: 41493727DERIVED

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 and biostatistical consultanat

Study Record Dates

First Submitted

October 30, 2024

First Posted

October 31, 2024

Study Start

January 12, 2021

Primary Completion

September 28, 2021

Study Completion

September 28, 2021

Last Updated

October 31, 2024

Record last verified: 2024-10

Locations

EG(1)