Clinical Study of BMP-2 Injectable Hydrogel for Promoting Alveolar Bone Regeneration

Study on Injectable Hydrogel Loaded With BMP-2 for Promoting Alveolar Bone Regeneration Induced by Periodontitis

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07611617

Enrollment

Registered

2026-05-28

Start date

2026-05-01

Completion date

2028-12-31

Last updated

2026-05-28

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

Conditions

Alveolar Bone Loss* / Therapy, Periodontitis

Keywords

Periodontitis, Alveolar Bone Loss* / therapy, BMP-2, Hydrogel

Brief summary

This project aims to construct an injectable self-healing hydrogel loaded with BMP-2, with optimized gelation time and mechanical strength to meet the requirements for periodontal pocket filling, for the treatment of periodontitis and acceleration of tissue repair, achieving a "bactericidal-anti-inflammatory-regenerative" trinity function. This project will provide a novel intelligent material for promoting alveolar bone regeneration in periodontitis and establish a theoretical paradigm for the precise intervention of oral infectious diseases.

Interventions

OTHERtreatment group

subgingival scaling + BMP-2 hydrogel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Clinical Diagnosis: Meets the 2018 International Classification of Periodontal Diseases, diagnosed with Stage III or IV periodontitis. * Bone Defect Characteristics: At least one affected tooth presents with a deep periodontal pocket (PPD ≥5 mm), and CBCT imaging confirms the presence of significant vertical bone resorption or angular bone defects (these defect types are most suitable for in-situ hydrogel filling and guided regeneration). * Age and General Condition: Aged between 18 and 70 years, any gender, generally in good systemic health. * Compliance and Consent: The subject is able to understand the study procedures, voluntarily sign the informed consent form, and commit to returning for follow-up visits as required (1, 3, 6, 12 months).

Exclusion criteria

* Systemic Interference with Bone Metabolism: Presence of poorly controlled diabetes (HbA1c \> 7%), osteoporosis, or long-term use of medications affecting bone metabolism such as bisphosphonates or glucocorticoids within the past six months. * Local Anatomical Limitations: The affected tooth has a vertical root fracture, severe periapical pathology, or a residual root that is deemed non-restorable and without preservation value. * Factors Interfering with Healing: Heavy smokers (average \> 10 cigarettes per day), as impaired microcirculation can significantly compromise the biological effects of the hydrogel. * Special Physiological Periods: Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame	Description
Vertical Bone Defect Fill Height (VBH)	Up to 12 month	Three-dimensional reconstruction using CBCT (Cone Beam Computed Tomography) to measure the change in distance from the base of the bone defect to the alveolar crest between pre-operative and post-operative scans.

Secondary

Measure	Time frame	Description
Clinical Periodontal Parameter Examination	Up to 12 month	Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), Gingival Recession Depth (GR), Bleeding on Probing (BOP).

Contacts

CONTACTWenjie Ren

13937354075@163.com8613937354075

PRINCIPAL_INVESTIGATORWenjie Ren

The First Affiliated Hospital of Xinxiang Medical College

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026