Effects of Vitamin D on Moderate to Severe Periodontitis

Study Overview
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Brief Summary
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The object of the study was to evaluate the direct effect of high dose vitamin D supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.

Detailed Description
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Periodontitis is a chronic inflammatory disease characterized by periodontal tissues inflammation and alveolar bone loss. Vitamin D is involved in stimulating osteoblasts to enable normal bone growth and preservation, also the regulation of cellular proliferation, differentiation, innate immune response and anti-inflammatory effect.Previous studies have reported the association of vitamin D levels and gingivitis and periodontitis. This study was designed as a randomized controlled trial to evaluate the effect of vitamin D supplementation on chronic periodontitis. The study was divided into two phases. Recruitment including baseline clinical measurements was obtained and standard periodontal treatments were performed in Phase One. The randomization and intervention of vitamin D were performed in Phase Two. The 323 subjects were randomly divided into 3 groups (n=105,110,108) to receive a supplement kit containing 90 capsules of 2000 IU vitamin D, 1000 IU vitamin D, or placebo capsule for 3 months. After intervention, all the subjects were followed up after 3 months and received standard periodontal examination, including attachment loss (AL), probing depth (PD), bleeding index (BI), and panoramic radiographs were taken to evaluate alveolar crest height (ACH).

Official Title
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Effects of Vitamin D on Chronic Periodontitis

Conditions
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Chronic Peritonitis

Intervention / Treatment
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* Dietary Supplement: vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 30 years old to 70 years old More than 20 teeth remaining in the mouth Clinical diagnosis of moderate to severe periodontitis Not receiving periodontal treatment within 6 months Not taking antibiotic drugs within 3 months. Exclusion Criteria: Diabetes, thyroid and parathyroid endocrine associated diseases Severe systemic diseases, such as cancer Taking vitamin D and / or calcium drugs during observation Taking aspirin, non-steroidal anti-inflammatory drugs, and steroids Pregnant or prepare to pregnant within one year Have been suffering from hypercalcemia, malabsorption syndrome.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2000IU/day<br>Subjects took 2000IU vitamin D per day | Dietary Supplement: vitamin D<br>* Subjects took vitamin D or placebo<br>|
| Experimental: 1000IU/day<br>Subjects took 1000IU vitamin D per day | Dietary Supplement: vitamin D<br>* Subjects took vitamin D or placebo<br>|
| Placebo Comparator: Placebo<br>Subjects took placebo | Dietary Supplement: vitamin D<br>* Subjects took vitamin D or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attachment Loss (AL) | Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects. | at baseline | 
| Attachment Loss (AL) | Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects. | 3 months after periodontal treatment | 
| Attachment Loss (AL) | Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects | 6 months after periodontal treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth (PD) | Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects. | at baseline | 
| Probing Depth (PD) | Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects. | 3 months after periodontal treatment | 
| Probing Depth (PD) | Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects. | 6 months after periodontal treatment | 
| Alveolar Crest Height (ACH) | Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point. | at baseline | 
| Alveolar Crest Height (ACH) | Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point. | 3 months after periodontal treatment | 
| Alveolar Crest Height (ACH) | Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point. | 6 months after periodontal treatment | 
| Bleeding Index (BI) | Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome. | at baseline | 
| Bleeding Index (BI) | Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome. | 3 months after periodontal treatment | 
| Bleeding Index (BI) | Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome. | 6 months after periodontal treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D