Edentulous Alveolar RidgeNCT05960916
Primary Stability of Immediate Implant Using Versah Versus Conventional Burs
A study testing Densah® burs and Conventional Burs in people with Edentulous Alveolar Ridge, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study is designed as a Prospective Randomized Clinical Trail, Evaluate the effect of osseodensification technique on primary stability in comparison to the conventional drilling technique in immediate single fresh extraction sockets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Densah® burs and Conventional Burs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIraq
- Study dates
- 22 Jan 2022to 1 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy and medically fit patients
- Patients age ≥18 years for both gender
- Apical bone ≥ 2mm from vertical structure showed in x-rays.
- Patient has tooth or teeth with single root anterior and\or posterior area cannot
- restored by another dental treatment procedure.
Who cannot join
- Patient with active periodontal disease.
- Pregnancy or lactation.
- A local or systemic disorder that is contraindicated for the minor surgical procedure
- and may affect healing process.
- Any irradiation in head and neck area.
- Heavy smoking habit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Stability of Immediate Dental Implant Using Osseodensification and Conventional Burs (A Randomized a Clinical Comparative Prospective Study)
This study is designed as a Prospective Randomized Clinical Trail, Evaluate the effect of osseodensification technique on primary stability in comparison to the conventional drilling technique in immediate single fresh extraction sockets.
Read the detailed description
In this study, 30 dental implants inserted immediately after tooth extraction (not a multi-rooted tooth) as a two groups according to bur drill technique and measure the primary stability by osstell devise based on resonance frequency analysis (RFA) value which is scaled from 1-100, after 16 weeks measuring the secondary stability.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Densah® burs, Conventional Burs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah® bursProcedure or surgery
Also called Study group
Osseodensification is a non-excavating implant site preparation technique, it creates a densified layer of surrounding bone through compaction autografting while simultaneously plastically expanding the bony ridge at the same time facilitating for placement of large diameter implants and also avoiding fenestration and dehiscence defects.
Conventional BursProcedure or surgery
Also called Control group
Conventional burs is the gold standard that used to prepare the osteotomy site by drilling of the bone and creating a bed for implant placement, it is used according to the manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| Densah® bur | Experimental | Densah is a bur that used for drilling of the alveolar ridge that have low bone density, narrow alveolar ridge, and sinus lifting procedure in dental implant preparation technique. Receives: Procedure: Densah® burs |
| Conventional bur | Active comparator | Conventional bur is the gold standard bur that used to prepare the osteotomy for dental implant. Receives: Procedure: Conventional Burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Implant Stability Quotient (ISQ)
immediately after implant placement the ISQ value measured by RFA device (Osstell)
Measured: baseline value of implant stability measured immediately after implant installation (primary stability)
Secondary outcomes (1)
Secondary Implant Stability Quotient (ISQ)
16 weeks after implant placement, ISQ value measured by RFA device (Osstell)
Measured: Changes in implant stability after 16 weeks (secondary stability) from baseline value measured immediately after implant placement (primary stability)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start22 Jan 2022
- Primary completion1 Jul 2023
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dividing two groups according drill type and parallelly measured during study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Thamer Naji, University of Baghdad
- Investigators
- Hasanain A. Al-Jumaily, C.A.B.M.S, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960916
- Sponsor's protocol ID
- 121189
- Status last verified
- Jul 2023
- First submitted
- 2 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Stability of Immediate Dental Implant Using Osseodensification and Conventional Burs (A Randomized a Clinical Comparative Prospective Study)
- ClinicalTrials.gov ID
- NCT05960916
- Acronym / sponsor ID
- 121189
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 27 Jul 2023 (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.
This study is designed as a Prospective Randomized Clinical Trail, Evaluate the effect of osseodensification technique on primary stability in comparison to the conventional drilling technique in immediate single fresh extraction sockets.
Detailed description
In this study, 30 dental implants inserted immediately after tooth extraction (not a multi-rooted tooth) as a two groups according to bur drill technique and measure the primary stability by osstell devise based on resonance frequency analysis (RFA) value which is scaled from 1-100, after 16 weeks measuring the secondary stability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Dividing two groups according drill type and parallelly measured during study
| Arm | Type | Receives |
|---|---|---|
| Densah® bur | Experimental | Procedure: Densah® bursDensah is a bur that used for drilling of the alveolar ridge that have low bone density, narrow alveolar ridge, and sinus lifting procedure in dental implant preparation technique. |
| Conventional bur | Active comparator | Procedure: Conventional BursConventional bur is the gold standard bur that used to prepare the osteotomy for dental implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy and medically fit patients
- Patients age ≥18 years for both gender
- Apical bone ≥ 2mm from vertical structure showed in x-rays.
- Patient has tooth or teeth with single root anterior and\or posterior area cannot
- restored by another dental treatment procedure.
Key exclusion criteria (6 listed)
- Patient with active periodontal disease.
- Pregnancy or lactation.
- A local or systemic disorder that is contraindicated for the minor surgical procedure
- and may affect healing process.
- Any irradiation in head and neck area.
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® bursAlso: Study groupOsseodensification is a non-excavating implant site preparation technique, it creates a densified layer of surrounding bone through compaction autografting while simultaneously plastically expanding the bony ridge at the same time facilitating for placement of large diameter implants and also avoiding fenestration and dehiscence defects. | Procedure or surgery | Densah® bur |
| Conventional BursAlso: Control groupConventional burs is the gold standard that used to prepare the osteotomy site by drilling of the bone and creating a bed for implant placement, it is used according to the manufacturer instructions. | Procedure or surgery | Conventional bur |
Primary outcome
Primary Implant Stability Quotient (ISQ)
Time frame: baseline value of implant stability measured immediately after implant installation (primary stability)
immediately after implant placement the ISQ value measured by RFA device (Osstell)
1 secondary outcome
Secondary Implant Stability Quotient (ISQ)
Time frame: Changes in implant stability after 16 weeks (secondary stability) from baseline value measured immediately after implant placement (primary stability)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Hasanain A. Al-Jumaily, C.A.B.M.S study director
University of Baghdad
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 Conventional Burs in people with Edentulous Alveolar Ridge, 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 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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. 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 Implant Stability Quotient (ISQ) (time frame: baseline value of implant stability measured immediately after implant installation (primary stability)). 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 27 Jul 2023.