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An exploratory clinical trial to explore the effectiveness and safety of biomimetic calcium phosphate (rhBMP-2/BioCaP/ß-TCP) as the bone substitute for socket preservation

An exploratory clinical trial to explore the effectiveness and safety of biomimetic calcium phosphate (rhBMP-2/BioCaP/ß-TCP) as the bone substitute for socket preservation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035263
Enrollment
Unknown
Registered
2020-08-05
Start date
2020-11-09
Completion date
Unknown
Last updated
2024-05-27

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 (rhBMP-2/BioCaP/ß-TCP)
B:ß-TCP
C:natural healing group

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. Oral implant placement contra-indication according to Hwang et al. 2. Patients with uncontrolled local inflammation of extracted teeth and adjacent teeth, including uncontrolled periodontitis (periodontal probing depth > 4mm) and acute periapical periodontitis; 3. Patients with stable diabetes, fasting blood glucose is still >= 8.8 mmol / L after drug control); 4. Patients with uncontrolled severe hypertension (higher than 180 / 100 mmHg); 5. In obese patients, BMI > 28 kg / m^2; 6. Patients who received antibiotic therapy or chronic anti-inflammatory therapy (more than 3 times a week) in the first 4 weeks before operation; 7. Smoking / tobacco equivalent / chewing tobacco more than 10 cigarettes per day; 8. Patients allergic to products; 9. Pregnant or lactating women or female patients who refuse to take contraceptive measures during clinical trials; 10. Patients with poor compliance who could not participate in the trial according to the researchers; 11. 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;

Secondary

MeasureTime frame
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;Surface area change of soft tissue in the sagittal plane at 6 weeks after tooth extraction;Soft tissue healing score at 6 weeks after tooth extraction;

Countries

China

Contacts

Public ContactWu Yiqun

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

yiqunwu@hotmail.com+86 139 1689 2306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026