Peri-implant Mucosal Changes Over Time Following Implant Provisional Removal in the Esthetic Zone
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLoma Linda University
About this trial
The study will examine the temporary volumetric change that happens in the gums around an implant crown when the crown is removed. The main question of the study is "how much time has to pass to see a significant change, especially when there could be a need to make a mold of the surrounding gum to make a new crown?"
The area of the implant crown will be scanned with an intra-oral scanner over a period of 15 minutes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must have a maxillary anterior immediate implant and provisionalization treatment completed.
The adjacent tooth next to the implant should be a natural tooth
The temporary crown must have been in place for a minimum of 4 months
The patient needs to be of general good health, with no significant medical history or social habits that might directly affect the hard and soft tissue
Disqualifiers
Patient with an implant crown that has no teeth next to the implant crown
Patients who have an active gum disease
Trial population
Patients selected for the participation in the study will be solely from the Center of Implant Dentistry at Loma Linda University School of Dentistry.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
intraoral scan
Other interventionDevice that scans the mouth with by taking numerous pictures of the mouth and stitches them together to form a three-dimensional copy of the patient teeth.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Peri-implant mucosal volumetric change
The mucosal volumetric change will be a composite measurement of the outside and inside portion of the peri-implant gum area by a 3D analyzing software. The 3D image that has been captured from an intra-oral scan will be analyzed during the time interval mentioned in the study description. This measurement is representing the horizontal change, and will be recorded in millimeters (mm). The critical analysis will be placed as changes from 0.5mm. Any change more than 0.5mm will be considered a large amount of change.
Time frame
Change between baseline and 15 minutes post initial crown removalSecondary outcomes
1
Vertical gingival margin discrepancy
This is the composite measure of the coronal-apical shift of the crown margin once the crown is removed. This would be the vertical change happening when you are looking straight at the subject. The vertical height will be measured from the actual crown margin to the resulting crown margin following crown removal, and the measurement will be recorded as millimeters (mm.) Any change more than 0.5mm will be considered a significant change.
Time frame
Change between baseline and 15 minutes post initial crown removalSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov