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Preliminary exploration of the effect of topical application of minocycline hydrochloride ointment on the clinical efficacy of chronic periodontitis with type II diabetes mellitus

Preliminary exploration of the effect of topical application of minocycline hydrochloride ointment on the clinical efficacy of chronic periodontitis with type II diabetes mellitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092305
Enrollment
Unknown
Registered
2024-11-14
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic periodontitis with type II diabetes mellitus

Interventions

Experimental group:minocycline hydrochloride ointment
Control group:placebo

Sponsors

Peking University Stomatological Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-70 years old; 2. Severe periodontitis (classified as stage III-IV according to the new classification of periodontal disease in 2018); 3. The remaining teeth in the mouth (except the teeth to be removed or cannot be retained) >=15; 4. 1 week after cleaning, >=4 teeth with probing depth PD>=6mm (except for affected teeth that cannot be retained and teeth that are III degree loose as assessed by doctors); 5. One week after treatment, the BOP of total oral probe bleeding was >30%; 6.In patients diagnosed with T2DM, HbA1c was <9.0%

Exclusion criteria

Exclusion criteria: 1.Periodontal cleaning in the past 1 month or regular root scaling in the past 3 months; 2.Severe or uncontrollable diabetic complications (nephropathy stage IV or above, proliferative diabetic retinopathy, etc.); 3.Serious or uncontrollable systemic diseases other than diabetes, including diseases of the heart, liver, kidney, respiratory, blood, endocrine, nervous and psychiatric systems; 4.Pregnancy or planning pregnancy or breastfeeding; 5.Alcohol dependence; 6.Have used antibiotics in the past 3 months; 7.Tetracycline drug allergy.

Design outcomes

Primary

MeasureTime frame
The change in probing depth of PD>=6mm sites at baseline from baseline to 6 months after treatment;Subgingival plaque sample;

Secondary

MeasureTime frame
The change of PD depth at baseline PD>=5mm from baseline to 6 months after treatment;Loss of attachment CAL;Plaque index PlI;Bleeding index BI;Glycosylated hemoglobin;IL-1ßIL-17calprotectin;

Countries

China

Contacts

Public ContactKaining Liu

Peking University School and Hospital of Stomatological

liukainingbjmu@163.com+86 134 6650 2549

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 14, 2026