Retrospective Observational Study of Implant-supported Restorations With Dental Implants.

M3 Health

Status: Active, not recruiting

Conditions: Oral Surgical Procedures

Treatments: Procedure: Dental Implants installed in an grafted area (ridge augmentation); Procedure: Dental Implants installed in an grafted area (sinus lifting); Procedure: Dental Implants installed in an grafted area (extraction sites)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06154057

Plenum Oss 002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Dental Implants installed in an grafted area (sinus lifting)

Experimental group

Description:

Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - sinus lifting.

Treatment:

Procedure: Dental Implants installed in an grafted area (sinus lifting)

Dental Implants installed in an grafted area (ridge augmentation)

Experimental group

Description:

Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - ridge augmentation.

Treatment:

Procedure: Dental Implants installed in an grafted area (ridge augmentation)

Dental Implants installed in an grafted area (extraction sites)

Experimental group

Description:

Dental implants produced by additive manufacturing installed in an area grafted with synthetic bone graft (Plenum® Osshp) - extraction sites (socket preservation or dental implant preparation/placement).

Treatment:

Procedure: Dental Implants installed in an grafted area (extraction sites)