Implant StabilityNCT04442763
The Effect of Osseodensification on Implant Stability in Posterior Maxilla
A study testing Densah Burs and Standard drills in people with Implant Stability, run by Cairo University at 1 site in Egypt.
Trial summary
Implants will be placed in posterior maxilla using two drilling methods; the osseodensification technique and conventional drilling protocols. Implant stability will be measured after implant placement , 1,2,3,4,6 and 8 weeks and 3 months later. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Stability
- What is being tested?
- Densah Burs and Standard drills
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2021to 20 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: >18 years; medically free,
- Partially edentulous patients in maxillary posterior area (premolar-molar area)
- Sufficient ridge height
- Sufficient ridge width
- Adequate soft tissue biotype.
- Patients with adequate inter-arch space for placement of implant prosthetic part.
- Cooperative patients with good oral hygiene
- Patients who accept to sign an informed consent.
Who cannot join
- Active periodontal diseases
- Parafunctional habits.
- History of radiation therapy to the head and neck
- Bone augmentation to implant site
- Smoking
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dental Implants Stability After Using Osseodensification Method Versus Conventional Drilling in the Posterior Maxilla: A Randomized Clinical Trial
Implants will be placed in posterior maxilla using two drilling methods; the osseodensification technique and conventional drilling protocols. Implant stability will be measured after implant placement , 1,2,3,4,6 and 8 weeks and 3 months later. Insertion torque will be evaluated at the termination of implant placement and crestal bone loss will be measured post-implant insertion, after 3 months and after 6 and 12 months of loading. Post-operative pain and patients' satisfaction will be assessed as well. implant survival will be assessed at the end of the follow up period
- Conditions
- Implant Stability
- Being tested
- Densah Burs, Standard drills
- Keywords
- Osseodensification, Densah burs, conventional drilling, implant stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah BursDevice
osseodensification method
Standard drillsDevice
conventional drilling
| Study group | Role | What they receive |
|---|---|---|
| Densah burs | Experimental | Osseodensification using Densah burs Receives: Device: Densah Burs |
| Standard drills | Active comparator | conventional drilling using standard drills Receives: Device: Standard drills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Implant stability will be measured using Osstell (Resonance Frequency Analysis). the measurement unit is Implant stability quotient (ISQ) (range 1-100)
Measured: immediately post-implant insertion, 1,2,3,4,6,8 weeks and 3 months
Secondary outcomes (2)
Crestal bone loss
Standardized periapical digital radiographs
Measured: immediately post-implant insertion - 3 months- 6 and 12 months post-loading
Insertion torque
torque wrench
Measured: at the termination of implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start3 Jan 2021
- Primary completion10 Dec 2022
- Study completion20 Dec 2023
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 Implant StabilityStudies 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, Sara Amr Abdel Raouf, Cairo University
- Investigators
- Omnia Aboul Dahab, Study director, Professor, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442763
- Sponsor's protocol ID
- Sara89
- Status last verified
- Dec 2024
- First submitted
- 15 Jun 2020
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Abdelraouf SA, Dahab OA, Mostafa B, Kenawy SM, Tawfik OK. Implant stability in the posterior maxilla: clinical and radiographic comparison of osseodensification and conventional drilling: a randomized clinical trial. Clin Oral Investig. 2025 Sep 29;29(10):480. doi: 10.1007/s00784-025-06526-8.
PubMed 41016918
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dental Implants Stability After Using Osseodensification Method Versus Conventional Drilling in the Posterior Maxilla: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04442763
- Acronym / sponsor ID
- Sara89
- Conditions
- Implant Stability
- Keywords
- Osseodensification, Densah burs, conventional drilling, implant stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 23 Jun 2020 (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.
Implants will be placed in posterior maxilla using two drilling methods; the osseodensification technique and conventional drilling protocols. Implant stability will be measured after implant placement , 1,2,3,4,6 and 8 weeks and 3 months later. Insertion torque will be evaluated at the termination of implant placement and crestal bone loss will be measured post-implant insertion, after 3 months and after 6 and 12 months of loading. Post-operative pain and patients' satisfaction will be assessed as well. implant survival will be assessed at the end of the follow up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Densah burs | Experimental | Device: Densah BursOsseodensification using Densah burs |
| Standard drills | Active comparator | Device: Standard drillsconventional drilling using standard drills |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: >18 years; medically free,
- Partially edentulous patients in maxillary posterior area (premolar-molar area)
- Sufficient ridge height
- Sufficient ridge width
- Adequate soft tissue biotype.
Key exclusion criteria (6 listed)
- Active periodontal diseases
- Parafunctional habits.
- History of radiation therapy to the head and neck
- Bone augmentation to implant site
- Smoking
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 Bursosseodensification method | Device | Densah burs |
| Standard drillsconventional drilling | Device | Standard drills |
Primary outcome
Implant stability
Time frame: immediately post-implant insertion, 1,2,3,4,6,8 weeks and 3 months
Implant stability will be measured using Osstell (Resonance Frequency Analysis). the measurement unit is Implant stability quotient (ISQ) (range 1-100)
2 secondary outcomes
Crestal bone loss
Time frame: immediately post-implant insertion - 3 months- 6 and 12 months post-loading
Insertion torque
Time frame: at the termination of implant insertion
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 3 Jan 2025.
- Derived from this study: PubMed 41016918Abdelraouf SA, Dahab OA, Mostafa B, Kenawy SM, Tawfik OK. Implant stability in the posterior maxilla: clinical and radiographic comparison of osseodensification and conventional drilling: a randomized clinical trial. Clin Oral Investig. 2025 Sep 29;29(10):480. doi: 10.1007/s00784-025-06526-8.
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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.
Omnia Aboul Dahab study director
Professor, Faculty of Dentistry, Cairo University
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 Standard drills in people with Implant Stability, 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 8 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 3 Jan 2025. 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: immediately post-implant insertion, 1,2,3,4,6,8 weeks and 3 months). 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 NCT04442763, 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 3 Jan 2025.