Research on the Development and Clinical Evaluation of Biomimetic Abutments

NCT06870955 | Recruiting

• 1 other identifier: 20211212
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Loss

Outcome Measures

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.

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

Secondary Outcomes (4)

• Changes in hard tissue contour

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

• Food impaction

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

• Plaque index

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

• Gingival index

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

Study Arms (1)

biomimetic abutment group

EXPERIMENTAL

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

Interventions

using biomimetic abutments PROCEDURE

The subjects recieved the biomimetic healing abutments during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.

biomimetic abutment group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• soft tissue grafting was needed
• severe acute or chronic periodontitis
• heavy smoking habit (\> 10 cigarettes/day)
• poor oral hygiene

Sponsors & Collaborators

• Stomatological Hospital Affiliated with Fujian Medical University: lead

Study Sites (1)

The Affiliated Stomatological Hospital of Fujian Medical University

Fuzhou, Fujian, 350002, China

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Hui Cheng, PhD

  Stomatological Hospital Affiliated with Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Cheng, PhD

CONTACT

18960883888; ch_fujian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Prosthodontics

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 11, 2025
• Study Start: November 23, 2023
• Primary Completion: September 25, 2025
• Study Completion: September 30, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)