Clinical trial NCT06154057: Retrospective Observational Study of Implant-supported Restorations With Dental Implants.
Official title: Retrospective Observational Study of Implant-supported Restorations With Implants Produced by Additive Manufacturing
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Oral Surgical Procedures
Keywords: Dental Implants
Synthetic Bone Graft
Additive Manufacture
Bone Loss
Success Rate
Lead sponsor: M3 Health
Sponsor class: INDUSTRY
Collaborators: name: University of Guarulhos
First posted: 2023-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft). In addition, the biological and biomechanical performance of implant restorations supported through an observational retrospective solution will be observed. From 50 to 100 survey participants will be selected, who will be invited to attend the clinic for clinical, radiographic, and prosthetic evaluation and successful parameters between baseline, 3, 6, and 12 months. The data obtained regarding bone loss (primary outcome) of the analyzed regions and implant success and survival in area grafted with Plenum® Osshp (secondary outcome) will be evaluated by the paired t-test for the evaluation of the times (3, 6, and 12 months) and survival curves of the installed dental implants.


Eligibility criteria: Inclusion Criteria:

Clinical parameters:

* Presence or absence of pain or tenderness
* Presence or absence of suppuration or exudation
* Presence or absence of mobility

Prosthetic parameters

- Presence or absence of mechanical complications (problems in prefabricated components such as screws and abutments).

Radiographic Parameters

* Presence or absence of peri-implant radiolucidity.
* maintenance and quality of the bone graft volume in the grafted area to each clinical indication: ridge augmentation, extraction sites (socket preservation or dental implant preparation/placement) and sinus lifting.
* Distance between the shoulder of the implant and the first visible bone contact (in mm).
* Presence or absence of technical complications such as fracture or loss of porcelain structures.

Success Parameters

* Absence of pain or tenderness.
* Absence of suppuration or exudation.
* Clinical absence of implant mobility.
* Absence of peri-implant radiolucency.
* Minor loss of up to 1.5mm in the first year of function.
* Absence of mechanical or technical complications in the dental implant and in the prosthesis to the dental implants installed in an area grafted.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).
timeFrame: 12 months
Secondary outcomes:
measure: The survival rate of dental implants produced by additive manufacturing installed in different areas grafted with synthetic bone grafts (Plenum® Osshp)
timeFrame: 12 months
measure: Rate of bone loss
timeFrame: 12 months
Other outcomes:
Locations:
city: Guarulhos
country: Brazil
facility: University of Guarulhos
state: Sao Paulo
Study officials:
affiliation: University of Guarulhos, UnG
name: Jamil A Shibli, PhD
role: PRINCIPAL_INVESTIGATOR
References: