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A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial to evaluate the safety and efficacy of oral biofilms

A prospective, multicenter, randomized, parallel controlled, non inferiority clinical trial to evaluate the safety and efficacy of oral biofilms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089731
Enrollment
Unknown
Registered
2024-09-13
Start date
2022-08-12
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Teeth extraction and filling repair

Interventions

control group:Geistlich Bio-Gide

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18 years old = Age = 65 years old, gender unlimited (2) Single tooth extractor (3) For those who have at least one intact adjacent tooth in the extracted tooth position (4) Those who voluntarily participate in this clinical trial and sign an informed consent form

Exclusion criteria

Exclusion criteria: (1) Individuals with intraoral artifacts that cause imaging examination in the surgical area (2) Patients with multiple (>2) alveolar bone wall defects (3) Progressive periodontal disease patients (4) Poor control of diabetes patients (fasting blood glucose = 7.0 mmol/L under drug control) (5) Individuals with heart disease (grade II and above heart function disorders) (6) Patients with liver and kidney dysfunction or abnormalities (ALT, AST, creatinine exceeding the upper limit of normal values and judged clinically significant by researchers) (7) Individuals with bleeding tendencies or coagulation disorders (platelet abnormalities or coagulation dysfunction, with clinical significance determined by the researchers) (8) Individuals with a history of local radiotherapy for the head or neck or who have taken bisphosphonates within 2 years prior to the trial (9) Systematically using drugs that may affect or promote bone metabolism, including calcitonin, parathyroid hormone, high-dose steroid hormone drugs (taken continuously for more than 3 months), immunosuppressants, and other drugs that researchers believe may affect bone metabolism, within the first 3 months prior to the experiment (10) Individuals who use drugs, alcohol, drugs, or self report smoking/tobacco equivalents/chewing tobacco with more than 10 cigarettes per day (11) Known allergy to sheep derived materials or collagen (12) Uncontrolled acute or chronic infections in the surgical area (13) Individuals with uncontrolled systemic diseases who are unable to undergo tooth extraction surgery (14) Pregnant/lactating women (15) Patients participating in clinical trials of other drugs or medical devices (16) Researchers believe that other patients who are not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
Changes in alveolar bone height at 24 weeks post surgery;

Secondary

MeasureTime frame
Performance evaluation of intraoperative instruments;Changes in horizontal width of alveolar bone at 24 weeks post surgery;Wound healing status at 2 and 12 weeks after surgery;

Countries

China

Contacts

Public ContactXiao Wang

Peking University Third Hospital

bysywangxiao@163.com+86 185 1115 4321

Outcome results

None listed

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