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Effect of 25 hydroxyvitamin D3 adjuvant periodontal non-surgical treatment on patients with chronic periodontitis and type 2 diabetes mellitus: a randomized, double-blind, placebo-control trial

Effect of 25 hydroxyvitamin D3 adjuvant periodontal non-surgical treatment on patients with chronic periodontitis and type 2 diabetes mellitus: a randomized, double-blind, placebo-control trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065974
Enrollment
Unknown
Registered
2022-11-21
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

chronic periodontitis with type 2 diabetes mellitus

Interventions

VD3 GROUP:taking VD3
Control group:Oral placebo treatment

Sponsors

School and Hospital of Stomatology, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis and treatment standard of ADA diabetes in 2022, blood glucose level HblAC >= 7; 2. Lack of serum VD3 level (= 35 years; 3. Periodontal clinical examination and curved tomography confirmed that the patients had stage III/IV periodontal inflammation (2018 new periodontal classification standard); 4. Willing and able to abide by the schedule of research visit, laboratory examination and other research procedures, and sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with history of the following medical conditions: ocular trauma, keratopathy or corneal laser treatment, and recent refractive surgery ( 3 times the upper limit of normal ULN and/or ALT > 3 times the upper limit of normal ULN and/or total bilirubin > 1.5 times ULN}, mental disorders; 3. Patients combined with malignant tumors, especially calcium and phosphorus metabolism, such as lung cancer, kidney cancer, etc.; 4. Patients with vitamin B12 deficiency, familial inherited peripheral neuropathy, or the presence of other neurological disorders or skin lesions that the investigator believes may potentially affect the assessment; 5. Patients who have difficulty in communicating and/or are unwilling to understand and abide by the treatment plan, or who cannot cooperate or are considered unsuitable for inclusion by the investigator; 6. Patients who were receiving supplemental therapy with active vitamin D (calcitriol, a -calcitriol, etc.).

Design outcomes

Primary

MeasureTime frame
Pocket Depth;

Secondary

MeasureTime frame
Clinical Attachment Loss;HbA1c;Gingival Index;Bleeding on Probing;

Countries

China

Contacts

Public ContactShaohua Ge

School and Hospital of Stomatology, Shandong University

shaohuage@sdu.edu.cn+86 18866817899

Outcome results

None listed

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