Research on the Development and Clinical Evaluation of Biomimetic Abutments

Not Applicable

Recruiting

• Conditions: Tooth Loss

• Registration Number: NCT06870955
• Lead Sponsor: Stomatological Hospital Affiliated with Fujian Medical University

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.

Study Timeline

• Study Start: 2023-11-23
• Status Verified: 2025-03
• Study First Submitted: 2025-03-01
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-09-25
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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).

Trial Locations

Locations (1)

The Affiliated Stomatological Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China