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Evaluation of the efficacy and safety of a resorbable bone grafting system for guided bone regeneration in oral implantology: a multicenter, open, randomized, parallel-controlled clinical trial

Evaluation of the efficacy and safety of a resorbable bone grafting system for guided bone regeneration in oral implantology: a multicenter, open, randomized, parallel-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075686
Enrollment
Unknown
Registered
2023-09-13
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Alveolar bone defects for which guided bone regeneration can be performed

Interventions

test group:Resorbable bone grafting system for oral implant therapy
control subjects:Bioresorbable Matrix Barrier(GUIDOR) for Oral Implant Treatment

Sponsors

Hospital Of Stomatology Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) 18 to 70 years old, gender is not limited; (2) Voluntarily participated in the trial and signed an informed consent form; (3) Those who need GBR bone augmentation due to insufficient bone at the alveolar bone level; (4) Good oral hygiene habits; (5) Those with single or two consecutive missing teeth.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of osteoporosis and bisphosphonate therapy; (2) Patients with a history of radiotherapy or chemotherapy within 5 years; (3) Adjacent teeth or surgical areas with uncontrolled inflammation, e.g., severe periodontitis, periapical disease, and soft tissue inflammatory fistulae; (4) Patients with systemic or localized bone diseases such as bone tuberculosis, bone cysts, bone tumors, etc; (5) Those with more than two consecutive units of missing teeth in the surgical area; (6) Women who are pregnant, lactating and have pregnancy plan within 1 year; (7) Long-term users of special drugs such as hormones, anticoagulants, etc; (8) Psychiatric patients, those with neurological disorders, such as epilepsy; (9) Endocrine metabolic diseases, hematologic diseases and uncontrolled cardiovascular diseases, such as diabetes mellitus, thyroid disease and hypothyroidism; (10) Patients who smoke more than ten cigarettes per day or have poor oral hygiene habits; (11) Other conditions that, in the opinion of the investigator, make participation in the trial unsuitable.

Design outcomes

Primary

MeasureTime frame
Percentage of the ratio of lip-side alveolar bone resorption thickness at 6 months postoperatively to lip-side alveolar bone thickness (including alveolar bone thickness and implanted bone powder thickness) in the immediate postoperative period;

Secondary

MeasureTime frame
Wound healing status;Satisfaction with the operation of the whole machine;

Countries

China

Contacts

Public ContactOu guomin

Hospital Of Stomatology Sichuan University

guominou66@yahoo.com+86 136 8804 7196

Outcome results

None listed

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