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An exploratory clinical trial to explore the effectiveness and safety of biomimetic calcium phosphate (BioReBone) as the bone substitute for socket preservation

An exploratory clinical trial to explore the effectiveness and safety of biomimetic calcium phosphate (BioReBone) as the bone substitute for socket preservation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035850
Enrollment
Unknown
Registered
2020-08-18
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-24

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

Conditions

Dentition defect

Interventions

A:Biomimetic calcium phosphate bone
B:Calcium phosphate bone meal

Sponsors

The Ninth People's Hospital Affiliated to medical school of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Patients with single tooth extraction in accordance with the indications of tooth extraction; 3. The subjects who met the indications for site preservation (eds-1 and eds-2 grades according to n. caplanis et al. (2005)); 4. Patients choose to receive implant therapy; 5. The subjects voluntarily signed the informed consent form before carrying out any research related trial steps.

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled local inflammation of extracted teeth and adjacent teeth, including uncontrolled periodontitis (periodontal probing depth > 4mm) and acute periapical periodontitis; 2. Patients with oral mucosal lesions (such as lichen planus, leukoplakia); 3. Patients with space occupying lesions (including cysts, tumors, etc.) in extracted teeth and adjacent teeth; 4. Patients with systemic diseases affecting bone healing, wound healing and dental implant treatment (if stable diabetes is not controlled, fasting blood glucose is still >= 8.8 mmol / L after drug control); 5. Patients with uncontrolled and stable severe hypertension (higher than 180 / 100 mmHg); 6. Contraindications of conventional implant surgery and oral surgery, including bone graft surgery; 7. Patients with heart disease (grade II and above cardiac function diseases); 8. Patients with liver and kidney dysfunction or abnormal; 9. In obese patients, BMI > 28 kg / m2; 10. Patients who have received full dose radiotherapy, local radiotherapy of head or neck; 11. Patients who need long-term high-dose steroid therapy; 12. Patients who have been treated with drugs (such as bisphosphonates) that may affect or promote bone metabolism and other patients with abnormal calcium and phosphorus metabolism in recent 3 months; 13. Patients who received antibiotic therapy or chronic anti-inflammatory therapy (more than 3 times a week) in the first 4 weeks before operation; 14. Patients with alcoholism or long-term drug abuse; 15. Patients with immune insufficiency; 16. Smoking / tobacco equivalent / chewing tobacco more than 10 cigarettes per day; 17. Physical or mental defects affect the objects of oral health care; 18. Patients allergic to products; 19. Pregnant or lactating women; 20. Patients with poor compliance who could not participate in the trial according to the researchers; 21. Within 30 days prior to the start of surgery (study day 0), patients participated in clinical trials of other drug devices.

Design outcomes

Primary

MeasureTime frame
The volume density of the new bone in biopsy samples at the tooth extraction site 6 weeks after preservation;Volume density of residual bone filling material in biopsy samples at tooth extraction site 6 weeks after preservation;The contour width and height of the hard tissue changed 6 weeks after tooth extraction;Changes in soft tissue contour volume at 6 weeks after tooth extraction;Soft tissue healing score at 6 weeks after tooth extraction;The parameters of blood routine;Blood biochemistry;Coagulation function;Serum immunoglobulin;Serum bone morphogenetic protein 2;OHIP14;

Countries

China

Contacts

Public ContactYu Dedong

The Ninth People's Hospital Affiliated to medical school of Shanghai Jiaotong University

107176862@qq.com+86 15921830591

Outcome results

None listed

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