Research on the Development and Clinical Evaluation of Biomimetic Abutments

This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.

Study Overview

• Status: Recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Procedure: using biomimetic abutments

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Cheng, PhD; Phone Number: 18960883888; Email: ch_fujian@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350002
      • Recruiting
      • The Affiliated Stomatological Hospital of Fujian Medical University
      • Contact: Hui Cheng, PhD; Phone Number: 18960883888; Email: ch_fujian@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: biomimetic abutment group; 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.	Procedure: using 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stomatological Hospital Affiliated with Fujian Medical University
• Investigators: Principal Investigator: Hui Cheng, PhD, The Affiliated Stomatological Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): September 25, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 20211212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No