Dental Implant StabilityNCT05390996
Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods
A study testing dental implant placement in people with Dental Implant Stability, run by University of Baghdad at 1 site in Iraq.
Trial summary
The aim of this study is to evaluate the effect of Osseodensification on implant stability during the healing period The objective of this study is to compare between dental implant stability after osteotomy site preparation using osseodensification technique and conventional drilling technique immediately after… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Stability
- What is being tested?
- dental implant placement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteIraq
- Study dates
- 5 Jan 2022to Jan 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
- medically fit patients ≥ 18 years of age including both genders
- alveolar ridges of sufficient vertical and horizontal dimensions
- bone density less than 850 Hounsfield units (HU) which corresponds to D3-D5 bone density according to Misch bone classification based on preoperative CBCT findings
Who cannot join
- Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification are not suitable for osseodensification.
- Patient with severe buccal plate undercut or concavity
- Active infection or inflammation in the implant zone
- Presence of any uncontrolled systemic diseases.
- Any patient need advance treatment such as sinus lifting and bone augmentation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods: A Randomized Controlled Study
The aim of this study is to evaluate the effect of Osseodensification on implant stability during the healing period The objective of this study is to compare between dental implant stability after osteotomy site preparation using osseodensification technique and conventional drilling technique immediately after implant installation (primary stability) , 6 week after the insertion of implant and 12 weeks later (secondary stability)
- Conditions
- Dental Implant Stability
- Being tested
- dental implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placementOther
dental implant placement by using a different drilling techniques
| Study group | Role | What they receive |
|---|---|---|
| condensation drilling technique | Active comparator | condensation of bone (osseodensefecation technique) Receives: Other: dental implant placement |
| conventional drilling technique | Sham comparator | control group Receives: Other: dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary stability
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Measured: 0 day (baseline)
stability at the dip period
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Measured: 6 week post surgery
secondary stability
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Measured: 12 week post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start5 Jan 2022
- Primary completion1 Sep 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant StabilityStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Abdulhakeem, University of Baghdad
- Investigators
- Salwan Y Bede, BDS,FIMBS, Principal investigator, University of Bagh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390996
- Sponsor's protocol ID
- dental implant
- Status last verified
- May 2022
- First submitted
- 7 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05390996
- Acronym / sponsor ID
- dental implant
- Conditions
- Dental Implant Stability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 25 May 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 aim of this study is to evaluate the effect of Osseodensification on implant stability during the healing period The objective of this study is to compare between dental implant stability after osteotomy site preparation using osseodensification technique and conventional drilling technique immediately after implant installation (primary stability) , 6 week after the insertion of implant and 12 weeks later (secondary stability)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| condensation drilling technique | Active comparator | Other: dental implant placementcondensation of bone (osseodensefecation technique) |
| conventional drilling technique | Sham comparator | Other: dental implant placementcontrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medically fit patients ≥ 18 years of age including both genders
- alveolar ridges of sufficient vertical and horizontal dimensions
- bone density less than 850 Hounsfield units (HU) which corresponds to D3-D5 bone density according to Misch bone classification based on preoperative CBCT findings
Key exclusion criteria (5 listed)
- Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification are not suitable for osseodensification.
- Patient with severe buccal plate undercut or concavity
- Active infection or inflammation in the implant zone
- Presence of any uncontrolled systemic diseases.
- Any patient need advance treatment such as sinus lifting and bone augmentation.
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 |
|---|---|---|
| dental implant placementdental implant placement by using a different drilling techniques | Other | condensation drilling technique, conventional drilling technique |
Primary outcome
primary stability
Time frame: 0 day (baseline)
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
stability at the dip period
Time frame: 6 week post surgery
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
secondary stability
Time frame: 12 week post surgery
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
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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.
Salwan Y Bede, BDS,FIMBS principal investigator
University of Bagh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant placement in people with Dental Implant Stability, run by University of Baghdad at 1 site in Iraq.
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 3 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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 Iraq. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
primary stability (time frame: 0 day (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2022.