Active — Not RecruitingNot Applicable

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

China50 participantsStarted 2022-05-20

Plain-language 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. 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The labial horizontal alveolar bone thickness

Timeframe: 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

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

Trial details

NCT IDNCT06020040

SponsorThe Dental Hospital of Zhejiang University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Implant Site Reaction trials