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Prospective cohort study of the osteogenetic effect of absorbable bovine pericardium collagen membrane guided bone regeneration

Prospective cohort study of the osteogenetic effect of absorbable bovine pericardium collagen membrane guided bone regeneration

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070538
Enrollment
Unknown
Registered
2023-04-14
Start date
2022-04-14
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Dentition defect

Interventions

Group of dentition defect (Guided bone regeneration):No

Sponsors

West China Stomatological Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged between 18 and 65 years old (including 18 years old and 65 years old), regardless of gender; 2) Single or multiple missing teeth with Terheyden 1/4~3/4 type labial bone plate defect, requiring GBR; 3) The patient is in good health and can tolerate the operation; 4) Subjects fully understand the benefits and risks of this trial, and are willing to participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Participated in other clinical trials within 4 weeks before the start of this trial; 2) Heart disease (i.e., class II and above heart function disease); liver and kidney dysfunction (ALT, AST > normal value 1.5 times; diabetic patients with poorly controlled blood sugar levels (fasting blood sugar still =8.0 mmol/L after control); 3) Patients with uncontrolled oral diseases, such as progressive periodontitis, severe periapical infection, and severe habitual bruxism; 4) Uncontrolled metabolic diseases such as diabetes, osteochondrosis, thyroid disease, and severe liver and kidney dysfunction; 5) Patients with bone diseases such as osteoporosis, osteomalacia, and osteosclerosis; 6) Various bone defects caused by malignant tumors, active infectious lesions, and metabolic bone diseases during the active period; 7) Patients with systemic infections or acute local infections at the surgical site; 8) Hematological diseases such as aplastic anemia, those who have taken anticoagulant drugs within the past 3 months or whose coagulation test results are not within the normal range; 9) Patients using drugs that may affect soft and hard tissue healing, 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 cortex hormones (continuous use for more than 3 months), or those who have received drug treatment that may affect or promote bone metabolism within the past 3 months; 10) Patients who smoke heavily (more than 20 cigarettes/day) within the past 6 months and during bone healing; 11) Autoimmune diseases; 12) Undergoing radiotherapy or having received head and neck radiotherapy within one year; 13) Mental illness, drug abuse, alcoholism; 14) Those with a clear history of collagen allergy; 15) Pregnant and lactating women. 16) Other conditions that researchers believe are not suitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Thickness of the labial bone plate;

Countries

China

Contacts

Public ContactAnchun Mo

West China Hospital of Stomatology

moanchun@163.com+86 13808062689

Outcome results

None listed

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