About this trial
This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
soft tissue grafting was needed
severe acute or chronic periodontitis
heavy smoking habit (> 10 cigarettes/day)
poor oral hygiene
Trial design
Single group
Treatments tested in this trial
using biomimetic abutments
Procedure/SurgeryThe subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.
Treatment groups
Trial outcomes
Primary outcomes
Changes in soft tissue contour
Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages.
Secondary outcomes
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.
Food impaction
Incidence of food impaction: Dichotomous registration, 0 = Absent; 1 = Present.
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).
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).
Sponsors and contacts
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