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Clinical study on the effect of vitamin D receptor FokI genotype on the responsiveness of vitamin D3-assisted periodontal therapy for severe periodontitis

Clinical study on the effect of vitamin D receptor FokI genotype on the responsiveness of vitamin D3-assisted periodontal therapy for severe periodontitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071336
Enrollment
Unknown
Registered
2023-05-11
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

severe periodontitis

Interventions

Control Group:Subgingival scaling and Root Planing
Low concentration group:Subgingival scaling and Root Planing+oral vitamin D3 1000IU/d
High concentration group:Subgingival scaling and Root Planing+oral vitamin D3 2000IU/d

Sponsors

Department of periodontology, School of Stomatology, China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Severe periodontitis, stage III or IV (new classification by European Union of Periodontology and American Academy of Periodontology), PD=6mm, maximum loss of interdental attachment =5mm, X-ray alveolar bone resorption More than 1/3 of the root length; (2) Age: 18-60 years old; (3) More than 20 natural teeth remaining in the oral cavity; (4) The subjects have not received periodontal system treatment within 6 months.

Exclusion criteria

Exclusion criteria: (1) smoking; (2) female pregnancy and lactation; (3) taking antibiotics and non-steroidal anti-inflammatory drugs within the past 3 months; (4) other systemic diseases that affect periodontal tissue (high blood pressure, AIDS, rheumatoid, tumor, etc.); (5) suffering from hypercalcemia and malabsorption syndrome; (6) taking any vitamin D and its analog supplements and/or calcium drugs before and at the current stage of the study; (7) Are using drugs that may interfere with vitamin D metabolism (such as phenobarbital, phenytoin, and glucocorticoids); (8) Have been exposed to direct sunlight for more than three hours a day or have used UV sunbathing within two months (9) intake of any other nutritional supplements.

Design outcomes

Primary

MeasureTime frame
Serum 25(OH)D levels;gingival crevicular fluid 25(OH)D levels;probing depth;clinical attachment level;Sulcus Bleeding Index;bleeding on probing;tooth mobility;Serum MMP-8 levels;gingival crevicular fluid MMP-8 levels;Serum IL-1ß levels;gingival crevicular fluid IL-1ß levels;Serum IL-4 levels;gingival crevicular fluid IL-4 levels;Serum OC levels;gingival crevicular fluid OC levels;Serum ALP levels;gingival crevicular fluid ALP levels;Serum RANKL levels;gingival crevicular fluid RANKL levels;

Countries

China

Contacts

Public ContactXiaolin Tang

Department of periodontology, School of Stomatology, China Medical University

lin_hope@sina.com+86 180 4022 9203

Outcome results

None listed

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