Implant Site Reaction Clinical Trial
Official title:
The Relationship Between Bone Particles Sizes and the Stability of Soft and Hard Tissue in Aesthetic Area :3-year Prospective Intervention Clinical Study
Verified date | August 2023 |
Source | The Dental Hospital of Zhejiang University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. Large bone particles may show better mechanical properties and better mechanical compression resistance. 2. Large bone particles may show more reasonable pore size and porosity, which may provide better environment for the growth of new bone. 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.
Status | Active, not recruiting |
Enrollment | 46 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 1) 18 years old and above - 2) Patients with missing maxillary anterior teeth and insufficient horizontal bone mass of alveolar ridge who indeed need GBR - 3) One-wall or two-wall bone defects - 4) There is no infection and tooth extraction residue at the implant site - 5) Simultaneous implant placement - 6) Subjects who voluntarily join the test cohort and sign the informed consent Exclusion Criteria: - 1) Severe periodontitis or uncontrolled periodontitis - 2) History of head and neck radiotherapy - 3) History of bisphosphonate administration and injection - 4) Uncontrolled severe systemic diseases - 5) Patients with heavy smoking - 6) Onlay bone graft is needed for bone resorption - 7) Three-wall or four-wall bone defects |
Country | Name | City | State |
---|---|---|---|
China | The Stomatologic Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The Dental Hospital of Zhejiang University School of Medicine |
China,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of Vertical facial alveolar bone level (VFBL) from baseline | The distance from implant shoulder to the highest point of middle facial bone plate | The operation day, 6 months after operation, 1/2/3-year after implant restoration | |
Primary | 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, 1/2/3-year after implant restoration | |
Secondary | The change of horizontal bone thickness from baseline Facial alveolar bone thickness (HFBT) | Horizontal bone thickness of implant shoulder (HFBT1) and 2mm below the shoulder (HFBT2). | The operation day, 6 months after operation, 1/2/3-year after implant restoration |
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