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A prospective, multicenter, randomized, parallel-controlled, noninferiority clinical trial study evaluating an autologous dental bone graft material preparation system for dentofacial bone augmentation surgery

A prospective, multicenter, randomized, parallel-controlled, noninferiority clinical trial study evaluating an autologous dental bone graft material preparation system for dentofacial bone augmentation surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084963
Enrollment
Unknown
Registered
2024-05-28
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Alveolar bone defect

Interventions

test group:Bone Augmentation Surgery using the Autologous Dental Bone Graft Material Preparation System from TOOTHBANK (Suzhou) Co.
control group:Surgical treatment with bone filler material from Geistlich Pharmaceuticals Ltd, Switzerland

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old, gender is not limited; 2. Presence of a tooth that needs to undergo extraction as a single tooth in position 4-7 with neighboring teeth on at least one side; 3. Expected minimum remaining bone wall of the alveolar bone >= 3 mm after extraction; 4. Sufficient source of autogenous teeth; 5. No acute inflammation of the periodontal tissues of the affected teeth; 6. Good compliance and those who can cooperate to complete the whole clinical trial; 7. Able to understand the purpose of the trial, participate voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. A long history of smoking and refusal to control it, with more than 10 cigarettes per day; 2. Systemic diseases that have not been effectively treated, such as uncontrolled hypertension and diabetes mellitus; 3. The presence of non-steroidal anti-inflammatory drugs, corticosteroids, tetracycline, bisphosphonates, or other drugs that affect bone regeneration within 6 months; 4. Presence of systemic or localized bone diseases, such as bone tuberculosis, osteitis, bone tumor, osteosclerosis, osteochondrosis, and severe osteoporosis; 5. Patients with severe oral or underlying diseases, such as severe periodontitis; 6. History of head and neck radiation therapy; 7. Combined coagulation disorders; 8. Those who cannot tolerate surgery; 9. Combined severe cardiac, pulmonary, hepatic, renal and other systemic diseases; 10. Women who are pregnant, breastfeeding or have a birth plan within six months; 11. Have participated or are participating in other clinical trials within 3 months; 12. Those who are considered by the investigator to be unsuitable for participation in clinical trials.

Design outcomes

Primary

MeasureTime frame
Alveolar bone width height change values at 6 months after tooth extraction;

Secondary

MeasureTime frame
Wound healing;Alveolar bone width height change values at 3 months after tooth extraction;Functional evaluation of instrument use;Instrument Stability Evaluation;

Countries

China

Contacts

Public ContactWang Linhong

Zhejiang Provincial People's Hospital

wanglinhong@hmc.edu.cn+86 139 8946 3992

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026