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NCT Number: NCT06870955

Research on the Development and Clinical Evaluation of Biomimetic Abutments

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

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Key information

Conditions

Tooth Loss Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Stomatological Hospital of Fujian Medical University

Fuzhou, Fujian, 350002, China

Location status: Recruiting

Location contact

Hui Cheng, PhD

CONTACT

[email protected]

18960883888

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in soft tissue contour

    Time frame: 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 outcomes

  1. Changes in hard tissue contour

    Time frame: 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.

  2. Food impaction

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

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

  3. Plaque index

    Time frame: 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).

  4. Gingival index

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Cheng, PhD

CONTACT

[email protected]

18960883888

Sponsors and collaborators

Lead sponsor

Stomatological Hospital Affiliated with Fujian Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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