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This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biomimetic abutment group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| using biomimetic abutments | Procedure | The subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in soft tissue contour | Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages. | before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hard tissue contour | Changes of hard tissue contour in height through periapical radiographs using a long-cone paralleling technique with a film holder. | immediately after restoration, six months after restoration, and 12 months after restoration |
| Food impaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Cheng, PhD | Contact | 18960883888 | ch_fujian@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Cheng, PhD | Stomatological Hospital Affiliated with Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Stomatological Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350002 | China |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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Incidence of food impaction： Dichotomous registration, 0 = Absent; 1 = Present. |
| immediately after restoration, six months after restoration, and 12 months after restoration |
| Plaque index | 0 = No plaque at the gingival margin; 1 = Thin plaque layer on the gingival margin, not easily visible on inspection but detectable by scraping with a probe; 2 = Moderate plaque accumulation at the gingival margin or interproximal surfaces; 3 = Heavy plaque accumulation in the gingival sulcus, at the gingival margin, or on interproximal surfaces. Mean values among the 6 sites were obtained (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). | immediately after restoration, six months after restoration, and 12 months after restoration |
| Gingival index | 0 = Normal gingiva; 1 = Slight gingival edema, no bleeding on probing; 2 = Gingival edema with bleeding on probing; 3 =Tendency for spontaneous bleeding or presence of ulceration. Mean values among the 6 sites were obtained (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual). | immediately after restoration, six months after restoration, and 12 months after restoration |