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Periodontal diseases - diabetes clinical trial project

Study on dynamic changes of oral microecology in patients with periodontal disease and type II diabetes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077843
Enrollment
Unknown
Registered
2023-11-21
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

periodontitis and diabetes mellitus

Interventions

Test group:Supragingival cleaning and polishing, subgingival scraping under local anesthesia and root surface leveling
Control group:Supragingival cleaning and polishing

Sponsors

Peking University Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: a. Age 20-70 years old; b. At least 20 teeth in the mouth (excluding the third permanent molar); c. No systemic disease; d. Periodontitis subjects: Stage ?-? extensive periodontitis (referring to the 2018 international consensus on the new classification of periodontitis and periplant-related diseases) and there were more than 8 sites with probing depth (PD) = 5mm; e. Diabetic subjects have been diagnosed with T2DM for at least 1 year; f.e) The diabetes treatment regimen has remained unchanged over the past 3 months (no change in dose, formulation, or route of administration).

Exclusion criteria

Exclusion criteria: a. Have received periodontal systemic therapy in the past 6 months; b. History of systemic antibiotic use in the past 1 month; c. Pregnant or lactating; d. Have a serious systemic disease other than type 2 diabetes (kidney disease, rheumatoid arthritis, liver dysfunction, stroke or history of stroke); e. Wear orthodontic devices or removable dentures; f. Oral mucosal disease; g. There are active oral infections such as periapical abscess and periodontal abscess.

Design outcomes

Primary

MeasureTime frame
HbA1c level;

Secondary

MeasureTime frame
Systemic clinical parameters (including HbA1c, fasting blood glucose, high-density lipoprotein, low-density lipoprotein, triglycerides, CRP);The difference of multiomics expression between saliva samples and gingival crevicular fluid samples;

Countries

China

Contacts

Public ContactZheng Shuguo

Peking University Hospital of Stomatology

1163497226@qq.com+86 10 8219 5958

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026