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

NCT07611617 | Not Yet Recruiting

• 1 other identifier: BMPIH-2026-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis; Alveolar Bone Loss* / Therapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Vertical Bone Defect Fill Height (VBH)

  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.

  Up to 12 month

Secondary Outcomes (1)

• Clinical Periodontal Parameter Examination

  Up to 12 month

Study Arms (1)

subgingival scaling

OTHER

Other: treatment group

Interventions

treatment group OTHER

subgingival scaling + BMP-2 hydrogel

subgingival scaling

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

MeSH Terms

Conditions

Periodontitis; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Officials

• Wenjie Ren

  The First Affiliated Hospital of Xinxiang Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjie Ren

CONTACT

8613937354075; 13937354075@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: May 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05