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

NCT07611630 | Not Yet Recruiting

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

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.

Conditions

Periodontitis

Keywords

Periodontitis; Hydrogel; Minocycline Hydrochloride

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)

Sham

PLACEBO COMPARATOR

Other: treatment group

Interventions

treatment group OTHER

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

Sham

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.

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.
• Drug Allergy: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

MeSH Terms

Conditions

Periodontitis; cyclopia sequence

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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