Assess Marginal Bone Height Changes Around Dental ImplantsNCT04800406
Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.
A study testing Dental Implants in people with Assess Marginal Bone Height Changes Around Dental Implants, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Assess Marginal Bone Height Changes Around Dental Implants
- What is being tested?
- Dental Implants
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jan 2019
- 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free from any systemic diseases affecting the bone metabolism.
- Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration.
- Residual alveolar ridge with adequate height and width.
- Angel's class I classification maxillo - mandibular relationship.
- Sufficient inter arch space
Who cannot join
- Smoker.
- Patients with parafunction habits (clenching or bruxism).
Trial locations and contacts
1 site in 1 country.
About this study
Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.
- Being tested
- Dental Implants
- Keywords
- Implant surface treatment, Marginal bone height, Cone beam computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ImplantsProcedure or surgery
Resorbable blast media surface treated dental implant and Acid etched surface treated dental implant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone height changes
The marginal bone changes around each type of dental implant were assessed by cone beam computed tomography.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess Marginal Bone Height Changes Around Dental ImplantsStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ten completely edentulous patients aged from 50-60 years
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nabil Elboraey, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800406
- Sponsor's protocol ID
- 16007
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.
- ClinicalTrials.gov ID
- NCT04800406
- Acronym / sponsor ID
- 16007
- Keywords
- Implant surface treatment, Marginal bone height, Cone beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 16 Mar 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.
Patients participating in this study were rehabilitated by mucosa supported maxillary complete denture and mandibular overdenture supported by two different surface treated implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by ball attachments. The marginal bone height changes around RBM and acid etched surface treated dental implants retaining mandibular complete overdenture were assessed by cone beam computed tomography.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Ten completely edentulous patients aged from 50-60 years
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Free from any systemic diseases affecting the bone metabolism.
- Healthy, firm covering mucosa which is free from any signs of Inflammation or ulceration.
- Residual alveolar ridge with adequate height and width.
- Angel's class I classification maxillo - mandibular relationship.
- Sufficient inter arch space
Key exclusion criteria (2 listed)
- Smoker.
- Patients with parafunction habits (clenching or bruxism).
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 ImplantsResorbable blast media surface treated dental implant and Acid etched surface treated dental implant. | Procedure or surgery | – |
Primary outcome
Marginal Bone height changes
Time frame: one year
The marginal bone changes around each type of dental implant were assessed by cone beam computed tomography.
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 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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 Dental Implants in people with Assess Marginal Bone Height Changes Around Dental Implants, run by National Research Centre, Egypt 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 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 16 Mar 2021. 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?
Marginal Bone height changes (time frame: one year). 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 16 Mar 2021.