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Clinical trial of plasma matrix bone mass used for horizontal bone increment before oral anterior teeth implantation

Clinical trial of plasma matrix bone mass used for horizontal bone increment before oral anterior teeth implantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078916
Enrollment
Unknown
Registered
2023-12-21
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dentition defect

Interventions

Experimental group:GBR treatment of bone defects in patients with dentition defects using collagen membrane (Bio gide), plasma matrix, and bone powder material (Bio oss)
Control group:GBR treatment of bone defects in patients with dentition defects using collagen membrane (Bio gide) and bone powder material (Bio oss)

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) The subjects voluntarily participate in the experiment and sign a written informed consent form; (2) Age range from 18 to 70 years old (including 18 and 70 years old), regardless of gender; (3) Full mouth plaque score<25%; (4) The clinical diagnosis of insufficient alveolar bone mass at the repair site requires GBR technology to supplement the bone mass. Can the patient change to have at least one missing tooth site at any location in the maxillary anterior dental aesthetics school district (13-23), requiring implant repair, with horizontal bone defects at the implant site and vertical bone defects less than 2mm; (5) The patient is clear in mind and has no barriers to understanding; (6) Patients have the willingness and ability to self-control oral hygiene after conducting oral hygiene education

Exclusion criteria

Exclusion criteria: (1) Pregnant, lactating women, and patients planning to conceive during the study period; (2) Patients with contraindications to oral surgery; (3) Those suffering from systemic diseases that may affect the postoperative healing period and/or bone union, such as diabetes (fasting blood glucose>8 mmol/L), uncontrolled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg), osteomalacia, thyroid diseases, etc; (4) Systemic or local bone diseases, such as bone tuberculosis, osteoarthritis, bone tumors, etc; (5) Patients with apical disease near the surgical area, or patients with apical cysts near the surgical area; (6) Uncontrolled infection throughout the body; (7) Severe hematological diseases, such as leukemia or other hemorrhagic diseases; (8) Patients with adjacent periodontal disease and advanced periodontal disease that have not yet been controlled; (9) Known or suspected malignant tumors; (10) Patients who have a history of radiation therapy or chemotherapy for the head and neck within the past 3 years, or are currently undergoing radiation therapy or chemotherapy; (11) Individuals who are taking or long-term taking special drugs that may affect postoperative healing or bone resorption (such as bisphosphonates and high-dose corticosteroids); (12) Abnormal liver and kidney function (liver ALT and AST values exceeding 1.5 times the upper limit of normal values, or creatinine exceeding 1.5 times the upper limit of normal values); (13) Individuals who are addicted to alcohol, drugs, or other drugs or have a tendency to become addicted; (14) Smoking more than ten cigarettes per day; (15) Patients with acute infection of hepatitis B (big three positive); (16) Positive individuals for HIV antibody preliminary screening, hepatitis C antibody, and Treponema pallidum specific antibody testing; (17) Patients who do not meet the requirements for implant restoration (such as metal allergies); (18) Patients have participated in other clinical trials within one month prior to the start of this trial; (19) Researchers believe that for other reasons, it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Changes in the width of the buccal and palatal bone at the implant site from the baseline period (before the same period of bone increment as implant surgery) to 6 months after surgery.;

Secondary

MeasureTime frame
Changes in bone height between adjacent spaces of implants from the beginning of loading to one year after loading;Survival of newly generated bone tissue after 1, 2, and 3 years of implant loading;Survival rate of implants after 1, 2, and 3 years of bearing capacity;Record the success of implant treatment according to the standards proposed by Onget et al. in 2008;Complications of implants and restorations; Other related complications: membrane exposure, edema, graft detachment, etc;

Countries

China

Contacts

Public ContactHongyu Yang

peking university shenzhen hospital

1259080684@qq.com+86 139 2525 3968

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026