- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06872177
Chart Review: Comparing the Position and Tilt of Dental Implants Versus Those of Natural Teeth
Axial Inclination of Mandibular Molar Dental Implants Versus Natural Teeth: What Are the Differences?
Background:
When placing a dental implant, it is not always possible to place it exactly in the same position as the tooth that it replaced. That might be because of how the gums and mouth are shaped, since some bone is always lost after a tooth is extracted. Researchers want to study the records of people who have had dental implants. They want to check to see how much difference there is between how the implant is positioned and how the same tooth on the other side is positioned. They also want to compare how the implant is positioned compared to the tooth it replaced, when that is possible in the dental record.
Study design:
This study will not enroll any participants. The researchers will search the database of patient records at the study clinic to find people who have had dental implants of a single molar tooth. Then they will look at them to find records that include good images that they can use to compare the implant and tooth positions.
Researchers will then analyze the findings and write a review article.
Study Overview
Detailed Description
This is a retrospective chart review. Specifically, the clinic e-chart system will be used to locate patients who received implant surgery. E-charts from January 1, 2016, to January 6, 2025, with pre- and post-implant surgery tomography (CBCT) documentation will be identified and used for this study.
Demographic and clinical data (age, sex, systemic conditions, implant details and surgical treatment outcomes) related to these cases will be collected. Radiographic measurements will include the following:
- On tomography: 1. Buccolingual axial inclination of natural molars and implants. 2. Mesiodistal axial inclination of natural molars and implants. 3. Presence/absence of fenestration and/or dehiscence around implants 4. Proximity to mandibular canal and/or foramen mentale
- On Panoramic radiograph: Mesiodistal axial inclination of natural molars and implants.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Binnaz Leblebicioglu, DDS, MS, PhD
- Phone Number: 614-292-0371
- Email: leblebicioglu.1@osu.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with mandibular molar implant placement.
- Presence of contralateral natural mandibular first, second molars or both.
- Availability of pre-extraction CBCT scans of the corresponding or contralateral mandibular molar tooth or panoramic radiographs for mesiodistal angulation.
- Availability of post-implant CBCT scans or panoramic radiographs for mesiodistal angulation
Exclusion Criteria:
- Incomplete or low-quality CBCT scans.
- History of mandibular trauma or pathologies altering tooth or implant alignment.
- History of reconstructive mandibular surgery in the implant region.
- History of periapical pathology
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Chart Review
Existing records of patients at the Ohio State University College of Dentistry who had a dental implant of one single molar tooth between January 1, 2016 and January 6, 2025
|
On existing identified chart records: measurements on CBCT and panographic radiographs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Replaced Tooth Comparison
Time Frame: Baseline (prior to tooth extraction), day 1 of implant placement, day 1 of crown placement (4-6 months after implant placement)
|
Difference in buccolingual and mesiodistal angulations of placed implant compared with pre-extraction natural tooth.
|
Baseline (prior to tooth extraction), day 1 of implant placement, day 1 of crown placement (4-6 months after implant placement)
|
|
Contralateral Tooth Comparison
Time Frame: Day 1 of implant placement, day 1 of crown placement (4-6 months after implant placement)
|
Difference in buccolingual and mesiodistal angulations of placed implant compared with contralateral natural molar.
|
Day 1 of implant placement, day 1 of crown placement (4-6 months after implant placement)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Fenestration/Dehiscence
Time Frame: Day 1 of crown placement (4-6 months post-implant placement)
|
Presence/absence of fenestration and/or dehiscence around implants
|
Day 1 of crown placement (4-6 months post-implant placement)
|
|
Distance from Foramen Mentale
Time Frame: Day 1 of crown placement (4-6 months post-implant placement)
|
Distance between the implant and the foramen mentale, measured with software on CBCT
|
Day 1 of crown placement (4-6 months post-implant placement)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Binnaz Leblebicioglu, DDS, MMS, PhD, Ohio State University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025H0006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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