Bone Deficiency, Posterior MaxillaeNCT02833337
Morphological Pattern of the Atrophic Posterior Maxillae
An observational study of Bone Deficiency, Posterior Maxillae, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are considered as the most challenging scenarios for implant-supported oral rehabilitation in modern implant dentistry. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Deficiency, Posterior Maxillae
- What is being tested?
- Cone-beam computed topography
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study used a retrospective database of preexisting data that included patients treated as part of routine periodontal and oral surgery therapy for each patient's needs. All the patients signed an inform consent approving using their radiographic data for research purposes.
- Images were included if:
- Pristine maxillary posterior atrophic ridges (between premolars and molars) as a result of missing single or multiple teeth for over than 12 months.
- Residual ridge height (RH) was < 10 mm.
- Presence of teeth adjacent to or opposing the edentulous area so the location of the edentulous ridges corresponding to the tooth site could be identified.
- The maxillary sinus to be measured was visible from its floor to at least 15 mm from the alveolar crest of the edentulous ridge.
- Images were excluded if:
- Images were unclear or incomplete due to scattering or other reasons
- Edentulous ridge height was more than 10 mm
- Ridge preservation/augmentation simultaneous/delayed to tooth extractions
- Grafted maxillary sinus for implant-supported prosthesis
- The location of the edentulous ridge cannot be determined
- Implants or other prosthetic device restoring the posterior ridge
- Presence of sinus pathology that made the measurement impossible
- The outline of the edentulous ridge cannot be identified due to low 'grey scale' density
Trial locations and contacts
1 site in 1 country.
About this study
Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are considered as the most challenging scenarios for implant-supported oral rehabilitation in modern implant dentistry. Therefore, a comprehensive and precise understanding of such anatomical structures are needed to avoid potential complications that ultimately might jeopardize the treatment outcome.
Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it offers a viable and reliable tool to study anatomical structures such as the posterior atrophic maxillae
- Conditions
- Bone Deficiency, Posterior Maxillae
- Being tested
- Cone-beam computed topography
- Keywords
- Bone, Maxilla, Cone-Beam Computed Tomography, Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone-beam computed topographyRadiation
This study used a retrospective database of preexisting data that included patients treated as part of routine periodontal and oral surgery therapy for each patient's needs. All the patients signed an inform consent approving using their radiographic data for research purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral Wall Thickness
Thickness measured in mm of the lateral aspect of the maxillary sinus
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Deficiency, Posterior MaxillaeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833337
- Sponsor's protocol ID
- 52/2012
- Status last verified
- Aug 2020
- First submitted
- 12 Jul 2016
- Last updated
- 17 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Pattern of the Atrophic Posterior Maxillae
- ClinicalTrials.gov ID
- NCT02833337
- Acronym / sponsor ID
- 52/2012
- Conditions
- Bone Deficiency, Posterior Maxillae
- Keywords
- Bone, Maxilla, Cone-Beam Computed Tomography, Regeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Posted 17 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are considered as the most challenging scenarios for implant-supported oral rehabilitation in modern implant dentistry. Therefore, a comprehensive and precise understanding of such anatomical structures are needed to avoid potential complications that ultimately might jeopardize the treatment outcome.
Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it offers a viable and reliable tool to study anatomical structures such as the posterior atrophic maxillae
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study used a retrospective database of preexisting data that included patients treated as part of routine periodontal and oral surgery therapy for each patient's needs. All the patients signed an inform consent approving using their radiographic data for research purposes.
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 |
|---|---|---|
| Cone-beam computed topographyThis study used a retrospective database of preexisting data that included patients treated as part of routine periodontal and oral surgery therapy for each patient's needs. All the patients signed an inform consent approving using their radiographic data for research purposes. | Radiation | – |
Primary outcome
Lateral Wall Thickness
Time frame: One month
Thickness measured in mm of the lateral aspect of the maxillary sinus
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bone Deficiency, Posterior Maxillae
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
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 Bone Deficiency, Posterior Maxillae, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Sep 2020. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 17 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lateral Wall Thickness (time frame: One month). 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 17 Sep 2020.