NCT06182670

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

The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement: 12-months, Parallel, Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

According to current literature, physiological bone loss around oral implants is expected after placement and load (1 mm during the first year and 0.2 mm each subsequent year). Different implant designs and surgical protocols have been tested to minimize bone resorption, and subcrestal implant placement partially seems to overcome this issue. However, if this procedure increases the length of the transmucosal tunnel, increasing the risk of peri-implant soft tissue infection. The GFA was created to limit both the loss of peri-implant crestal bone and the extension of the transmucosal tunnel. The GFA follows the "one abutment one time" concept, which is believed to limit disturbances of the peri-implant hard and soft tissues healing due to the removal of the traditional healing abutments during prosthetic load procedures. Our objective is to validate or deny this claim. The study is a monocentric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design. The trial will have a one-year duration, with data collection at the surgical phase, at implant load and 6 and 12 months after load. The primary outcome will be radiographical MBL (marginal bone level) changes around the implant. Secondary outcomes will be the assessment of the peri-implant soft tissues.

Conditions

• Edentulous Alveolar Ridge

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-06
• Primary completion: 2023-06-07
• Completion: 2023-06-07
• First posted: 2023-12-27
• Last updated: 2023-12-27

Locations

1 site across 1 country: Italy