Research on the Development and Clinical Evaluation of Biomimetic Abutments

Stomatological Hospital Affiliated with Fujian Medical University

Status: Enrolling

Conditions: Tooth Loss

Treatments: Procedure: using biomimetic abutments

Study type: Interventional

Funder types: Other

Identifiers

NCT06870955

20211212

Details and patient eligibility

About

This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.

Full description

The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.

To assess soft tissues, digital models were collected in STL files at five time points: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration. These models were analyzed using 3D software for model matching and measurement based on CBCT, focusing on the changes on soft tissue height, width, and volume.

Hard tissue evaluation was conducted through periapical radiographs taken at three time points: immediately after restoration, six months after restoration, and 12 months after restoration.

Additionally, general clinical conditions were assessed at the same three time points, evaluating parameters such as food impaction, plaque index, and gingival index.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 25 and 65 years old
• had one single edentulous site
• implant embedded healed and required secondary surgery to expose
• good treatment compliance and could attend follow-up appointment regularly

Exclusion criteria

• soft tissue grafting was needed
• severe acute or chronic periodontitis
• heavy smoking habit (> 10 cigarettes/day)
• poor oral hygiene

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

biomimetic abutment group

Experimental group

Description:

The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration. Historical or external data from other sources were used as controls to evaluate the treatment efficacy in the experimental group.

Treatment:

Procedure: using biomimetic abutments