NCT02833337

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 years until next milestone

Results Posted

Study results publicly available

September 17, 2020

Completed
Last Updated

September 17, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

July 12, 2016

Results QC Date

January 30, 2017

Last Update Submit

August 29, 2020

Conditions

Keywords

BoneMaxillaCone-Beam Computed TomographyRegeneration

Outcome Measures

Primary Outcomes (1)

  • Lateral Wall Thickness

    Thickness measured in mm of the lateral aspect of the maxillary sinus

    One month

Interventions

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 Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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: 1. Pristine maxillary posterior atrophic ridges (between premolars and molars) as a result of missing single or multiple teeth for over than 12 months. 2. Residual ridge height (RH) was \< 10 mm. 3. 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. 4. 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: 1. Images were unclear or incomplete due to scattering or other reasons 2. Edentulous ridge height was more than 10 mm 3. Ridge preservation/augmentation simultaneous/delayed to tooth extractions 4. Grafted maxillary sinus for implant-supported prosthesis 5. The location of the edentulous ridge cannot be determined 6. Implants or other prosthetic device restoring the posterior ridge 7. Presence of sinus pathology that made the measurement impossible 8. The outline of the edentulous ridge cannot be identified due to low 'grey scale' density

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Florencio Monje Gil

Badajoz, 06001, Spain

Location

Results Point of Contact

Title
Alberto Monje
Organization
Centro de Implantologia, Cirugia Oral y Maxilofacial

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 17, 2020

Results First Posted

September 17, 2020

Record last verified: 2020-08

Locations