Evaluation of Implant Stability in Low Quality Bone Following the Use of Osseodensifiers Versus Ridge Expanders

NCT ID: NCT05330546

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Bone Density

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Osseodensification technique group

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

Group Type EXPERIMENTAL

Densah burs

Intervention Type PROCEDURE

using Densah burs to prepare implant osteotomy

Ridge expansion screw group

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

Group Type ACTIVE_COMPARATOR

Ridge expansion screws

Intervention Type PROCEDURE

using Ridge expansion screws to prepare implant osteotomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Densah burs

using Densah burs to prepare implant osteotomy

Intervention Type PROCEDURE

Ridge expansion screws

using Ridge expansion screws to prepare implant osteotomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mariam Samir Nabih

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed El Barbary, Assis. prof.

Role: PRINCIPAL_INVESTIGATOR

Main supervisor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40963121 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12722

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.