Research on the Development and Clinical Evaluation of Biomimetic Abutments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: using biomimetic abutments.
- Who it may be relevant to
- Registry conditions: Tooth Loss. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.
Detailed 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.
Interventions
- Procedure using biomimetic abutments
The subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
Primary outcome measures
- Changes in soft tissue contour [Time frame: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration]
Secondary outcome measures (4)
- Changes in hard tissue contour [Time frame: immediately after restoration, six months after restoration, and 12 months after restoration]
- Food impaction [Time frame: immediately after restoration, six months after restoration, and 12 months after restoration]
- Plaque index [Time frame: immediately after restoration, six months after restoration, and 12 months after restoration]
- Gingival index [Time frame: immediately after restoration, six months after restoration, and 12 months after restoration]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Affiliated Stomatological Hospital of Fujian Medical University — Fuzhou
Identifiers
NCT: NCT06870955 · 20211212