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A clinical study of guided bone regeneration with simultaneous immediate restoration in aesthetic region

Compare the effect of GBR with and without flap on the changes of soft and hard tissues in immediate implant with implant restoration in the case of labial bone plate defect: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034616
Enrollment
Unknown
Registered
2020-07-12
Start date
2020-07-31
Completion date
Unknown
Last updated
2020-07-13

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:with flap
Control group:flapless

Sponsors

West China Stomatological Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults over 18 years old; 2. Implant restoration was required in the anterior area (13-23); 3. The height defect of labial bone plate ( 35Ncm); 5. Good occlusion and good oral health.

Exclusion criteria

Exclusion criteria: 1. Heart disease (heart function disease of grade II and above); Abnormal liver and kidney function (ALT and AST > 1.5 times the upper limit of normal value; patients with diabetes, poor control of blood glucose level (fasting blood glucose is still >= 8.0mmol /L after control); 2. Patients with uncontrolled oral diseases, such as progressive periodontal disease, severe periapical infection, and severe habitual molar disease; 3. Uncontrolled metabolic diseases such as diabetes, rickets, thyroid disease, and severe liver and kidney dysfunction; 4. Patients with osteoporosis, osteomalacia and osteosclerosis; 5. Malignant tumors, active infectious lesions, and bone defects in the active phase of metabolic bone disease; 6. Systemic infection or local acute infection of the surgical site; 7. Aplastic anemia and other blood diseases, taking anticoagulant drugs or coagulation tests for 3 months is not within the normal range; 8. The use of drugs that may affect the healing of hard and soft tissues, such as long-term use of sedative hypnotics (continuous use for more than 3 months), long-term use of non-steroidal anti-inflammatory drugs or adrenal corticosteroids (continuous use for more than 3 months), and the treatment of patients who have received drugs in the current or recent 3 months that may affect or promote bone metabolism; 9. Patients with severe smoking (smoking more than 20 cigarettes/day) in the past 6 months and during bone healing; 10. Autoimmune diseases; 11. Radiation therapy is under way; 12. Mental illness, drug abuse and alcohol abuse; 13. Known allergic to the materials used in the product; 14. Women in pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Bone thickness;Soft tissue contour;

Secondary

MeasureTime frame
Pink esthetic score;Papilla index score;Wound healing;Implant survival rate;

Countries

China

Contacts

Public ContactMo Anchun

West China Stomatological Hospital of Sichuan University

moanchun@qq.com+86 13808062689

Outcome results

None listed

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