Bone Particles Sizes and the Stability of Soft and Hard Tissue in Aesthetic Area

NCT06020040 | Active Not Recruiting

• 1 other identifier: DHZhejiangU-2022（061）
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

After implant restoration, the surrounding tissue, including the gingiva and alveolar bone, will inevitably reconstruct. The study found that gingival recession was easy to occur in the aesthetic area of upper anterior teeth within 1 year after implantation, which was mainly due to the absorption of labial alveolar bone. In order to avoid absorption, the thickness of the labial bone plate should not be less than 2mm, which is difficult to achieve in the anterior tooth area. Therefore, guided bone regeneration (GBR) should be performed in the implant area, which can provide more than 5mm bone increment in the vertical and horizontal positions with long-term stability, being beneficial for the maintenance of the buccal contour and the stability of the soft and hard tissues in the aesthetic area. In this study, the inorganic bone matrix extracted from bovine bone (Geistlich, Gegreen, Haiao, etc.) was used for GBR in the area with insufficient bone volume in the anterior dental implant area. The commercially available xenogeneic bone graft substitutes can be divided into large particles (1-2mm) and small particles (0.25-1mm) according to the particle size. Previous studies have found that in 6 months after implantation, the change of vertical bone height around the implant (i.e. the height from the top of alveolar ridge to the shoulder of the implant) is related to the particle size of bone powder, and large particles of bone powder may have better performance in maintaining the vertical bone height due to the following reasons:

1. 1.Large bone particles may show better mechanical properties and better mechanical compression resistance.
2. 2.Large bone particles may show more reasonable pore size and porosity, which may provide better environment for the growth of new bone.
3. 3.Large bone particles may achieve more reasonable and balanced bone remodeling. However, the effect of bone particle sizes on the maintenance of soft and hard tissue around the bone graft area is still inconclusive. Thus, the purpose of this study is to compare the effects of large and small bone particle sizes on the stability of soft and hard tissues around the bone graft area within 3 years after implant restoration in the anterior tooth area.

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (2)

• The labial horizontal alveolar bone thickness

  Horizontal bone thickness of implant shoulder, 2mm below the shoulder, 4mm below the shoulder, and 6mm below the shoulder.

  pre-surgery, immediately post-surgery, 6 months after operation, 1/2/3-year after implant restoration

• The change of Pink esthetic score (PES) from baseline

  Gingival tissue information collection include mesial and distal gingival papilla, soft tissue color, texture, level and contour, and alveolar ridge. The minimum value is 0, and the maximum value is 14, the higher scores mean a better outcome.

  The day of completion of implant restoration, 0.5/1/2/3-year after implant restoration

Secondary Outcomes (1)

• The change of Vertical facial alveolar bone level (VFBL) from baseline

  The operation day, 6 months after operation, 1/2/3-year after implant restoration

Study Arms (2)

Large Bone Particles

EXPERIMENTAL

The size of the bone particles that will be used for GBR is 1-2mm.

Device: Heterograft

Small Bone Particles

EXPERIMENTAL

The size of the bone particles that will be used for GBR is 0.25-1mm.

Device: Heterograft

Interventions

Heterograft DEVICE

Heterograft (Geistlich, Gegreen, Heal-All) will be used to repair bone defect in the esthetic area of the anterior teeth with simultaneous implant placement. According to the bone particle size, it can be divided into large bone particles(1-2mm) and small bone particles(0.25-1mm).

Large Bone Particles; Small Bone Particles

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 18 years old and above
• \) Patients with missing maxillary anterior teeth and insufficient horizontal bone mass of alveolar ridge who indeed need GBR
• \) One-wall or two-wall bone defects
• \) There is no infection and tooth extraction residue at the implant site
• \) Simultaneous implant placement
• \) Subjects who voluntarily join the test cohort and sign the informed consent

You may not qualify if:

• \) Severe periodontitis or uncontrolled periodontitis
• \) History of head and neck radiotherapy
• \) History of bisphosphonate administration and injection
• \) Uncontrolled severe systemic diseases
• \) Patients with heavy smoking
• \) Onlay bone graft is needed for bone resorption
• \) Three-wall or four-wall bone defects

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Stomatologic Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (2)

• Zhou Y, Gao J, Sheng M, Qi W, Jin J, He F. Facial alveolar bone alterations and gray value changes based on cone beam computed tomography around maxillary anterior implants: A clinical retrospective study of 1-3 years. Clin Oral Implants Res. 2020 May;31(5):476-487. doi: 10.1111/clr.13583. Epub 2020 Feb 12.

  PMID: 31990412 BACKGROUND

• Kheur MG, Kheur S, Lakha T, Jambhekar S, Le B, Jain V. Does Graft Particle Type and Size Affect Ridge Dimensional Changes After Alveolar Ridge Split Procedure? J Oral Maxillofac Surg. 2018 Apr;76(4):761-769. doi: 10.1016/j.joms.2017.11.002. Epub 2017 Dec 2.

  PMID: 29202263 BACKGROUND

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Li Weida

  Stomatological Hospital Affiliated to Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This study takes a single-blind method. During research process, the researchers cannot avoid knowing the type of abutment used by the subjects during the clinical examination and operation, so the subjects can only be single-blinded. The clinical examination data will be measured and averaged by two independent clinicians. The data will be analyzed by a third person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The researchers prospectively and continuously recruited subjects who underwent implant therapy with xenogeneic bone graft material in the Oral Implantation Center of the Stomatology Hospital Affiliated to Zhejiang University School of Medicine, and all subjects who signed written informed consent were divided into 2 groups (large bone particles and small bone particles) through a table of random numbers.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: August 31, 2023
• Study Start: May 20, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)