Low Bone DensityNCT05330546
Evaluation of Implant Stability in Low Quality Bone Following the Use of Osseodensifiers Versus Ridge Expanders
A study testing Densah burs and Ridge expansion screws in people with Low Bone Density, run by Cairo University at 1 site in Egypt.
Trial summary
the use of osseodensification technique compared to ridge expansion screws in low bone quality Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Bone Density
- What is being tested?
- Densah burs and Ridge expansion screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Stability of Implants Placed in Low Quality Bone Following the Use of Osseodensification Technique Versus Ridge Expanders: Randomized Clinical Trial
the use of osseodensification technique compared to ridge expansion screws in low bone quality
Read the detailed description
using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone
- Conditions
- Low Bone Density
- Being tested
- Densah burs, Ridge expansion screws
- Keywords
- osseodensification, ridge expansion screw
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah bursProcedure or surgery
using Densah burs to prepare implant osteotomy
Ridge expansion screwsProcedure or surgery
using Ridge expansion screws to prepare implant osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Osseodensification technique group | Experimental | 10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs Receives: 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 Receives: Procedure: Ridge expansion screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
assessing the stability using Osstell
Measured: change from baseline at 3 month
Implant stability
assessing the stability using Osstell
Measured: change from baseline at 6 month
Secondary outcomes (7)
Radiographic bone density
using CBCT in mm
Measured: change from baseline at 3 month
Radiographic bone density
using CBCT in mm
Measured: change from baseline at 6 month
Change in crestal bone level
using CBCT in mm
Measured: change from baseline at 3 month
Change in crestal bone level
using CBCT in mm
Measured: change from baseline at 6 month
Change in buccolingual bone width
using CBCT in mm
Measured: change from baseline at 3 month
Change in buccolingual bone width
using CBCT in mm
Measured: change from baseline at 6 month
Patient reported outcomes
10 mm Visual analogue scale from 1 to 10 with 1 minimal pain and 10 worst pain experience
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Bone DensityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Samir Nabih, Cairo University
- Investigators
- Ahmed El Barbary, Assis. prof., Principal investigator, Main supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330546
- Sponsor's protocol ID
- 12722
- Status last verified
- Sep 2022
- First submitted
- 2 Apr 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: raw data will be shared upon request
Publications
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.
PubMed 40963121
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Stability of Implants Placed in Low Quality Bone Following the Use of Osseodensification Technique Versus Ridge Expanders: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05330546
- Acronym / sponsor ID
- 12722
- Conditions
- Low Bone Density
- Keywords
- osseodensification, ridge expansion screw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the use of osseodensification technique compared to ridge expansion screws in low bone quality
Detailed description
using Densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osseodensification technique group | Experimental | Procedure: Densah burs10 patients will be randomly assigned to the osseodensification group so the implant osteotomy will be prepared using densah burs |
| Ridge expansion screw group | Active comparator | Procedure: Ridge expansion screws10 patients will be randomly assigned to the ridge expansion screw group so the implant osteotomy will be prepared using ridge expansion screws |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Single tooth missing in the maxillary region with D3 (350-850 HU) and D4 (150-350 HU) bone (Sultana et al., 2020).
Key exclusion criteria (5 listed)
- Systemic conditions/diseases that contraindicate surgery (Jarikian et al., 2021).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Densah bursusing Densah burs to prepare implant osteotomy | Procedure or surgery | Osseodensification technique group |
| Ridge expansion screwsusing Ridge expansion screws to prepare implant osteotomy | Procedure or surgery | Ridge expansion screw group |
Primary outcome
Implant stability
Time frame: change from baseline at 3 month
assessing the stability using Osstell
Implant stability
Time frame: change from baseline at 6 month
assessing the stability using Osstell
7 secondary outcomes
Radiographic bone density
Time frame: change from baseline at 3 month
Radiographic bone density
Time frame: change from baseline at 6 month
Change in crestal bone level
Time frame: change from baseline at 3 month
Change in crestal bone level
Time frame: change from baseline at 6 month
Change in buccolingual bone width
Time frame: change from baseline at 3 month
Change in buccolingual bone width
Time frame: change from baseline at 6 month
Patient reported outcomes
Time frame: at time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 40963121Nabih 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.
- Individual participant dataSharing planned: Yes. raw data will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed El Barbary, Assis. prof. principal investigator
Main supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Densah burs and Ridge expansion screws in people with Low Bone Density, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: change from baseline at 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05330546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.