Small sample clinical pretrial study on a novel bone repair material -- serine modified gelatin sponge

A small sample clinical pretrial study to evaluate a novel bone repair material, serine modified gelatin sponge

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400091059

Enrollment

Unknown

Registered

2024-10-20

Start date

2024-10-30

Completion date

Unknown

Last updated

2024-10-21

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

Conditions

Oral and maxillofacial tissue defects

Interventions

Experimental group:A new bone repair material - serine modified gelatin sponge for repairing bone defects

Control group:Guy's Bio-Oss Collagen bone filling materials/collagen

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 50 years old, regardless of gender; (2) Affected teeth that need to be removed due to severe periodontitis; Probing depth >6mm; Loss of attachment =5 mm; Alveolar bone resorption exceeds 1/2 root length; The posterior teeth had root bifurcation lesions of degree ? and above. (3) There are at least 2 remaining bone walls, and the remaining height of the bone wall is =3mm; (4) The four follow-up points can be guaranteed to be complete (1 month, 3 months, 6 months, 1 year after surgery); (5) The presence of at least one adjacent tooth; (6) After periodontal basic treatment, can maintain good oral health condition. All patients agreed to participate in the experiment and have signed informed consent; (7) Patients with no obvious surgical contraindications.

Exclusion criteria

Exclusion criteria: (1) Allergic constitution; (2) The affected tooth is in the acute infection stage; (3) Have a history of systemic disease or infection; (4) Long-term use of corticosteroids, non-steroidal anti-inflammatory drugs, bisphosphonates and other related drugs that affect bone metabolism; (5) The patient is pregnant or preparing for pregnancy; (6) History of head and neck radiotherapy; (7) can not guarantee timely treatment, no partner; (8) There is a disease that has an impact on the test results; (9) Patients with mental illness.

Design outcomes

Primary

Measure	Time frame
The healing rate of tooth cavity defect;Overall quality control and tracking of the test;	—

Secondary

Measure	Time frame
Surgical area satisfaction;	—

Countries

China

Contacts

Public ContactBolei Cai

Air Force Medical University

caibolei1020@126.com+86 136 0928 1084

Outcome results

None listed

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