Clinical Study of Minocycline Hydrochloride Injectable Hydrogel for the Treatment of Periodontitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: treatment group.
- Who it may be relevant to
- Registry conditions: Periodontitis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Construction of a Long-Acting Sustained-Release Minocycline Hydrochloride Delivery System Based on Hyaluronic Acid-Nanoclay Composite Hydrogel and Its Application in the Treatment of Periodontitis
Overview
This study aims to construct and systematically evaluate a multifunctional synergistic drug delivery system based on a hyaluronic acid-nanoclay composite hydrogel to achieve integrated treatment of periodontitis encompassing "infection control, inflammation regulation, and bone regeneration promotion." Through material design, in vitro functional validation, and in vivo efficacy evaluation, the study will elucidate the intrinsic relationships and synergistic mechanisms among "material structure, controlled drug release, and biological effects" within this system, thereby providing a theoretical basis and experimental foundation for the development of smart periodontal regenerative materials with clinical translational potential.
Interventions
- Other treatment group
hyaluronic acid-nanoclay composite hydrogel (containing HA-Pam/MH@Laponite).
Primary outcome measures
- Vertical Bone Defect Fill Height (VBH) [Time frame: Up to 12 month]
Secondary outcome measures (1)
- Clinical Periodontal Parameter Examination [Time frame: Up to 12 month]
Eligibility criteria
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.
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.
- Drug Allergy: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07611630 · MHIH-2026-01