Research on the Development and Clinical Evaluation of Biomimetic Abutments

ConditionTooth Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorStomatological Hospital Affiliated with Fujian Medical University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • using biomimetic abutments

    Procedure/Surgery

    The 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

30 Participants
are divided into 1 treatment group
Group A: biomimetic abutment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in soft tissue contour

Changes of soft tissue contour in height, width, and volume by matching digital models at different treatment stages.

Time frame
before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration

Secondary outcomes

1

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.

Time frame
immediately after restoration, six months after restoration, and 12 months after restoration
2

Food impaction

Incidence of food impaction: Dichotomous registration, 0 = Absent; 1 = Present.

Time frame
immediately after restoration, six months after restoration, and 12 months after restoration
3

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).

Time frame
immediately after restoration, six months after restoration, and 12 months after restoration
4

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).

Time frame
immediately after restoration, six months after restoration, and 12 months after restoration

Other outcomes

Sponsors and contacts

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