Dental ImplantNCT06667778
Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region
A study testing Osseodesification densah burs and Microdent in people with Dental Implant and Bone Expantion, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Dental Implant, Bone Expantion
- What is being tested?
- Osseodesification densah burs and Microdent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2021to 28 Sep 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: Effectiveness of Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region (a Randomized Controlled Clinical Trial)
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.
- Conditions
- Dental Implant, Bone Expantion
- Being tested
- Osseodesification densah burs, Microdent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MicrodentDevice
Also called Conventional manual bone expanders
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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Device: Osseodesification densah burs |
| Control group | Active comparator | Not described Receives: Device: Microdent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in implant stability
Implant stability will be measured using the Ostell device.
Measured: Baseline and 16 weeks
Secondary outcomes (3)
Change in bone density
The patients will be examined radiographically using CBCT
Measured: Baseline and 16 weeks
Change in ridge expansion
The patients will be examined radiographically using CBCT
Measured: Baseline and 16 weeks
Change in bone loss
The patients will be examined radiographically using CBCT
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start12 Jan 2021
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
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 Dental ImplantStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667778
- Sponsor's protocol ID
- 0105-12
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41493727
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06667778
- Acronym / sponsor ID
- 0105-12
- Conditions
- Dental Implant, Bone Expantion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 31 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Osseodesification densah burs |
| Control group | Active comparator | Device: Microdent |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Osseodesification densah bursDrill 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. | Device | Study group |
| MicrodentAlso: Conventional manual bone expandersNo. 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 | Device | Control group |
Primary outcome
Change in implant stability
Time frame: Baseline and 16 weeks
Implant stability will be measured using the Ostell device.
3 secondary outcomes
Change in bone density
Time frame: Baseline and 16 weeks
Change in ridge expansion
Time frame: Baseline and 16 weeks
Change in bone loss
Time frame: Baseline and 16 weeks
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 31 Oct 2024.
- Derived from this study: PubMed 41493727Hammouda 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osseodesification densah burs and Microdent in people with Dental Implant and Bone Expantion, run by Hams Hamed Abdelrahman 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 5 inclusion and 6 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 31 Oct 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?
Change in implant stability (time frame: Baseline and 16 weeks). 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 NCT06667778, 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 31 Oct 2024.