Tooth Loss
Conditions
Brief summary
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
PROCEDUREusing 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.
Sponsors
Stomatological Hospital Affiliated with Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in soft tissue contour | before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration | Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hard tissue contour | immediately after restoration, six months after restoration, and 12 months after restoration | Changes of hard tissue contour in height through periapical radiographs using a long-cone paralleling technique with a film holder. |
| Food impaction | immediately after restoration, six months after restoration, and 12 months after restoration | Incidence of food impaction： Dichotomous registration, 0 = Absent; 1 = Present. |
| Plaque index | immediately after restoration, six months after restoration, and 12 months after restoration | 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). |
| Gingival index | immediately after restoration, six months after restoration, and 12 months after restoration | 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). |
Countries
China
Contacts
Primary ContactHui Cheng, PhD
Outcome results
None listed