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

NCT06154057 | Unknown

• 1 other identifier: Plenum Oss 002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Dental Implants; Synthetic Bone Graft; Additive Manufacture; Bone Loss; Success Rate

Outcome Measures

Primary Outcomes (1)

• The survival rate of dental implants produced by additive manufacturing installed in pristine bone and grafted areas with synthetic bone graft (Plenum® Osshp).

  The main outcome is the survival rate (%) of successful implant-supported restoration after at least 1-year of occlusal loading (less than 0.5mm of bone loss)

  12 months

Secondary Outcomes (2)

• The survival rate of dental implants produced by additive manufacturing installed in different areas grafted with synthetic bone grafts (Plenum® Osshp)

  12 months

• Rate of bone loss

  12 months

Study Arms (3)

Dental Implants installed in an grafted area (sinus lifting)

EXPERIMENTAL

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

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

Dental Implants installed in an grafted area (ridge augmentation)

EXPERIMENTAL

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

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

Dental Implants installed in an grafted area (extraction sites)

EXPERIMENTAL

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).

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

Interventions

Dental Implants installed in an grafted area (sinus lifting) PROCEDURE

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

Also known as: maxillary sinus lift

Dental Implants installed in an grafted area (sinus lifting)

Dental Implants installed in an grafted area (ridge augmentation) PROCEDURE

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

Also known as: Guided bone regeneration

Dental Implants installed in an grafted area (ridge augmentation)

Dental Implants installed in an grafted area (extraction sites) PROCEDURE

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

Also known as: Guided bone regeneration

Dental Implants installed in an grafted area (extraction sites)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• M3 Health: lead
• University of Guarulhos: collaborator

Study Sites (1)

University of Guarulhos

Guarulhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jamil A Shibli, PhD

  University of Guarulhos, UnG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 1, 2023
• Study Start: January 1, 2019
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2023-11

Locations

BR (1)