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

ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Xinxiang Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • treatment group

    Other intervention

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: ShamPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Up to 12 month

Secondary outcomes

1

Clinical Periodontal Parameter Examination

Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), Gingival Recession Depth (GR), Bleeding on Probing (BOP).

Time frame
Up to 12 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: