Clinical Study of Minocycline Hydrochloride Injectable Hydrogel for the Treatment of Periodontitis

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07611630

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

Periodontitis

Keywords

Periodontitis, Hydrogel, Minocycline Hydrochloride

Brief summary

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

OTHERtreatment group

hyaluronic acid-nanoclay composite hydrogel (containing HA-Pam/MH@Laponite).

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.

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.

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