Clinical trial NCT06872177: Chart Review: Comparing the Position and Tilt of Dental Implants Versus Those of Natural Teeth
Official title: Axial Inclination of Mandibular Molar Dental Implants Versus Natural Teeth: What Are the Differences?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Implant
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Existing records of patients at the Ohio State University College of Dentistry who have had a dental implant of one single molar tooth, between January 1, 2016 and January 6, 2025

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Replaced Tooth Comparison
timeFrame: Baseline (prior to tooth extraction), day 1 of implant placement, day 1 of crown placement (4-6 months after implant placement)
measure: Contralateral Tooth Comparison
timeFrame: Day 1 of implant placement, day 1 of crown placement (4-6 months after implant placement)
Secondary outcomes:
Other outcomes:
measure: Frequency of Fenestration/Dehiscence
timeFrame: Day 1 of crown placement (4-6 months post-implant placement)
measure: Distance from Foramen Mentale
timeFrame: Day 1 of crown placement (4-6 months post-implant placement)
Locations:
Study officials:
affiliation: Ohio State University
name: Binnaz Leblebicioglu, DDS, MMS, PhD
role: PRINCIPAL_INVESTIGATOR
References: