NCT05330546

Brief Summary

the use of osseodensification technique compared to ridge expansion screws in low bone quality

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration 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

April 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 19, 2024

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

April 2, 2022

Last Update Submit

November 16, 2024

Conditions

Low Bone Density

Keywords

osseodensificationridge expansion screw

Outcome Measures

Primary Outcomes (2)

  • Implant stability

    assessing the stability using Osstell

    change from baseline at 3 month

  • Implant stability

    assessing the stability using Osstell

    change from baseline at 6 month

Secondary Outcomes (7)

  • Radiographic bone density

    change from baseline at 3 month

  • Radiographic bone density

    change from baseline at 6 month

  • Change in crestal bone level

    change from baseline at 3 month

  • Change in crestal bone level

    change from baseline at 6 month

  • Change in buccolingual bone width

    change from baseline at 3 month

  • +2 more secondary outcomes

Study Arms (2)

Osseodensification technique group

EXPERIMENTAL

10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs

Procedure: Densah burs

Ridge expansion screw group

ACTIVE COMPARATOR

10 patients will be randomly assigned to the ridge expansion screw group so the implant osteotomy will be prepared using ridge expansion screws

Procedure: Ridge expansion screws

Interventions

Densah bursPROCEDURE

using Densah burs to prepare implant osteotomy

Osseodensification technique group
Ridge expansion screwsPROCEDURE

using Ridge expansion screws to prepare implant osteotomy

Ridge expansion screw group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020).
  • A minimum of 4 mm residual buccolingual bone width at site of implant placement (Koutouzis et al., 2019).
  • The recipient site of the implant should be free from any pathological conditions.
  • No diagnosed bone disease or medication known to affect bone metabolism.
  • Patients who are cooperative, motivated and hygiene conscious.
  • Patients having adequate inter-occlusal space of 8-10 mm (Fernández et al., 2017)

You may not qualify if:

  • Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021).
  • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers (Vollmer et al., 2020).
  • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (Sultana et al., 2020).
  • Alcohol or drug abuse (Ibrahim et al., 2020).
  • Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • Nabih MS, Ashour OAM, Abbas WM, ElBarbary A. Evaluation of the stability of implants placed in low-quality bone following the use of osseodensification technique versus ridge expanders:randomized clinical trial. BMC Oral Health. 2025 Sep 17;25(1):1413. doi: 10.1186/s12903-025-06918-y.

    PMID: 40963121DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ahmed El Barbary, Assis. prof.

    Main supervisor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 15, 2022

Study Start

April 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 19, 2024

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

raw data will be shared upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
upon request for 2 days
Access Criteria
file including the raw data

Locations

EG(1)