Horizontal Ridge DeficiencyNCT04748952
Ridge Expansion by Osseodensification
An observational study of Horizontal Ridge Deficiency, run by University of Baghdad at 1 site in Iraq.
Trial summary
A prospective observational clinical study guided by the guidelines of Strengthening the Reporting of Observational Studies in Epidemiology (STORBE) in 2014, that conducted to assess amount of ridge expansion obtained by using Dansah burs with simultaneous implant placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- Densah burs
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 26 Jan 2021to 30 Oct 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Healthy adults with missing one or more tooth with horizontal alveolar bone defect seeking for dental implant treatment
Who may be able to join
- Healthy adult patients (≥ 18 years) with American Society of Anesthesiologist physical status classification level I (ASA I), of either gender, having single or multiple missing teeth in the maxilla and/or mandible with alveolar ridge width of 3-6 mm measured at the crest using CBCT.
- Patients should have ≥ 2 mm of trabecular bone core and ≥ 1/1 trabecular to cortical bone ratio to achieve a predictable expansion according to manufacture instruction in ridge expansion protocol provided by Versah©.
- Adequate vertical bone height of the alveolar ridge for placement of a minimum length of 8 mm dental implant length based on preoperative OPG or CBCT.
- Patients who were willing to comply with the study and were available for follow-up visits.
Who cannot join
- 1. Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification(16)) are not suitable for osseodensification.
- 2. Patient with severe buccal plate undercut or concavity. 3. Active infection or inflammation in the implant zone. 4. Presence of any uncontrolled systemic diseases. 5. Patients with a history of radiotherapy to the head and neck.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Osseodensification for Ridge Expansion and Dental Implant Placement in Narrow Alveolar Ridges: A Prospective Observational Clinical Study
A prospective observational clinical study guided by the guidelines of Strengthening the Reporting of Observational Studies in Epidemiology (STORBE) in 2014, that conducted to assess amount of ridge expansion obtained by using Dansah burs with simultaneous implant placement.
Read the detailed description
In this study, 40 implants will be installed in osteotomy sites prepared by Densah burs (osseodensification preparation technique) for patients with horizontal bone deficiency based on radiographic findings (CBCT).
Alveolar ridge width will be measured intraoperatively before and after osteotomy site preparation to assess the amount of ridge expansion. Implant stability will be measured immediately after implant installation and 16 weeks later.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- Densah burs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Densah bursDevice
Also called Osseodensification
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. The autografting occurs along the entire length of the osteotomy through a hydrodynamic process with the use of irrigation. The result is a consistently cylindrical and densified osteotomy.
| Study group | Role | What they receive |
|---|---|---|
| Adult with horizontal bone defect | 30 implants will be placed in osteotomy sites prepared by osseodensification for patients with horizontal bone deficiency based on radiographic findings (CBCT).
Alveolar ridge width will be measured intraoperatively before and after osteotomy site preparation to assess the amount of ridge expansion. Implant stability will be measured immediately after implant installation and 16 weeks later. Receives: Device: Densah burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge width
Buccolingual alveolar ridge width measured by using bone caliper at the crest before and after osteotomy preparation to assess amount of expansion obtained
Measured: 0 day
Secondary outcomes (1)
Implant stability
Implant stability will be measured using resonance frequency analysis (RFA) by Osstell Beacon device.
Measured: T0= Primary implant stability measured immediately after implant installation , T1 = secondary implant stability measured after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start26 Jan 2021
- Primary completion1 Aug 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Ridge DeficiencyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosol Dawod Salman, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748952
- Sponsor's protocol ID
- 19931993
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Osseodensification for Ridge Expansion and Dental Implant Placement in Narrow Alveolar Ridges: A Prospective Observational Clinical Study
- ClinicalTrials.gov ID
- NCT04748952
- Acronym / sponsor ID
- 19931993
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 10 Feb 2021 (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.
A prospective observational clinical study guided by the guidelines of Strengthening the Reporting of Observational Studies in Epidemiology (STORBE) in 2014, that conducted to assess amount of ridge expansion obtained by using Dansah burs with simultaneous implant placement.
Detailed description
In this study, 40 implants will be installed in osteotomy sites prepared by Densah burs (osseodensification preparation technique) for patients with horizontal bone deficiency based on radiographic findings (CBCT).
Alveolar ridge width will be measured intraoperatively before and after osteotomy site preparation to assess the amount of ridge expansion. Implant stability will be measured immediately after implant installation and 16 weeks later.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult with horizontal bone defect | – | Device: Densah burs30 implants will be placed in osteotomy sites prepared by osseodensification for patients with horizontal bone deficiency based on radiographic findings (CBCT). Alveolar ridge width will be measured intraoperatively before and after osteotomy site preparation to assess the amount of ridge expansion. Implant stability will be measured immediately after implant installation and 16 weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy adults with missing one or more tooth with horizontal alveolar bone defect seeking for dental implant treatment
Key inclusion criteria (4 listed)
- Healthy adult patients (≥ 18 years) with American Society of Anesthesiologist physical status classification level I (ASA I), of either gender, having single or multiple missing teeth in the maxilla and/or mandible with alveolar ridge width of 3-6 mm measured at the crest using CBCT.
- Patients should have ≥ 2 mm of trabecular bone core and ≥ 1/1 trabecular to cortical bone ratio to achieve a predictable expansion according to manufacture instruction in ridge expansion protocol provided by Versah©.
- Adequate vertical bone height of the alveolar ridge for placement of a minimum length of 8 mm dental implant length based on preoperative OPG or CBCT.
- Patients who were willing to comply with the study and were available for follow-up visits.
Key exclusion criteria (2 listed)
- 1. Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification(16)) are not suitable for osseodensification.
- 2. Patient with severe buccal plate undercut or concavity. 3. Active infection or inflammation in the implant zone. 4. Presence of any uncontrolled systemic diseases. 5. Patients with a history of radiotherapy to the head and neck.
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: OsseodensificationOsseodensification 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. The autografting occurs along the entire length of the osteotomy through a hydrodynamic process with the use of irrigation. The result is a consistently cylindrical and densified osteotomy. | Device | Adult with horizontal bone defect |
Primary outcome
Alveolar ridge width
Time frame: 0 day
Buccolingual alveolar ridge width measured by using bone caliper at the crest before and after osteotomy preparation to assess amount of expansion obtained
1 secondary outcome
Implant stability
Time frame: T0= Primary implant stability measured immediately after implant installation , T1 = secondary implant stability measured after 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 5 Apr 2022.
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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?
An observational study of Horizontal Ridge Deficiency, 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 4 inclusion and 2 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 5 Apr 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. 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?
Alveolar ridge width (time frame: 0 day). 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 5 Apr 2022.