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A multi-center, randomized, single-blind, parallel controlled clinical trial for natural calcined porous bone repair materials for the evaluation of the safety and effectiveness of alveolar ridge site preservation

A multi-center, randomized, single-blind, parallel controlled clinical trial for natural calcined porous bone repair materials for the evaluation of the safety and effectiveness of alveolar ridge site preservation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031948
Enrollment
Unknown
Registered
2020-04-15
Start date
2019-04-29
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

Save the extraction site

Interventions

test group:Implanted natural calcined porous bone repair material

Sponsors

Shandong Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 65 years old; 2) Single tooth or multiple tooth extraction and delayed implant treatment or fixed tooth restoration requiring bone graft; 3) Those who have not participated in other clinical trials within 6 months; 4) The subjects volunteered to participate in this clinical trial and signed the "Informed Consent Form" (ICF).

Exclusion criteria

Exclusion criteria: 1) Patients with acute periapical periodontitis, severe periodontitis, and moderate to severe gingivitis; 2) Patients who have been treated with drugs (except vitamin D) that may affect bone metabolism within or within the past 3 months; 3) Those who have been treated with bisphosphonate drugs within 3 months before surgery; 4) Abnormal fasting blood glucose and abnormal glucose tolerance test (glucose tolerance test is required when fasting blood glucose is> 5.6 mmol / L, glucose tolerance value at 0 hours> 7.0 mmol / L or 2 hours> 11.1 mmol / L) 5) Heart disease (level ? and above heart function diseases); 6) Abnormal liver and kidney function (AST, ALT> 1.5 times normal value; creatinine exceeds normal value); 7) Those with positive immunization tests (AIDS, hepatitis, syphilis), and / or "hepatitis B surface antigen, e antigen, e antibody, core antibody" positive in five hepatitis B tests; 8) Women who are pregnant or breastfeeding and who plan to become pregnant within 6 months; 9) Patients with orthodontic tooth extraction; 10) Those who are undergoing radiotherapy and chemotherapy; 11) Patients with abnormal coagulation or long-term oral anticoagulation; 12) The investigator believes that it is inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Alveolar ridge width change;

Secondary

MeasureTime frame
Alveolar ridge height change;

Countries

China

Contacts

Public ContactDongsheng Zhang

Shandong Provincial Hospital

ds63zhang@sdu.edu.cn+86 13791125330

Outcome results

None listed

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