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

NCT ID: NCT06154057

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-07-30

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.

Conditions

Oral Surgical Procedures

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dental Implants installed in an grafted area (sinus lifting)

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

Group Type: EXPERIMENTAL

Dental Implants installed in an grafted area (sinus lifting)

Intervention Type: PROCEDURE

The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.

Dental Implants installed in an grafted area (ridge augmentation)

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

Group Type: EXPERIMENTAL

Dental Implants installed in an grafted area (ridge augmentation)

Intervention Type: PROCEDURE

The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.

Dental Implants installed in an grafted area (extraction sites)

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).

Group Type: EXPERIMENTAL

Dental Implants installed in an grafted area (extraction sites)

Intervention Type: PROCEDURE

The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.

Interventions

Dental Implants installed in an grafted area (sinus lifting)

The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.

Intervention Type: PROCEDURE

Dental Implants installed in an grafted area (ridge augmentation)

The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.

Intervention Type: PROCEDURE

Dental Implants installed in an grafted area (extraction sites)

The patient will be invited to participate in the clinic to assess radiographic bone loss and clinical follow-up for 12 months.

Intervention Type: PROCEDURE

Other Intervention Names

maxillary sinus lift; Guided bone regeneration; Guided bone regeneration

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Guarulhos

OTHER

Sponsor Role: collaborator

M3 Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamil A Shibli, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guarulhos, UnG

Locations

University of Guarulhos

Guarulhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Plenum Oss 002

Identifier Type: -

Identifier Source: org_study_id