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The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement

NCT06182670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-27

No results posted yet for this study

Summary

The present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement.

The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA.

Clinical and radiographic examination will be performed at implant placement surgery, prosthetic load, 6 and 12 months follow-up.

Conditions

  • Edentulous Alveolar Ridge

Interventions

DEVICE

Gingival Former Abutment

GFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel.

PROCEDURE

Subcrestal Implant

Placement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone.

DEVICE

Healing Abutment

A healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization.

DEVICE

Prosthetic Crown

A zirconia prosthetic crown finalizes the implant rehabilitation.

PROCEDURE

Crestal Implant

Placement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone.

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • Magda Mensi · ASST Spedali Civili di Brescia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-06
Primary Completion
2023-06-07
Completion
2023-06-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06182670 on ClinicalTrials.gov