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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2000IU/day | Experimental | Subjects took 2000IU vitamin D per day |
|
| 1000IU/day | Experimental | Subjects took 1000IU vitamin D per day |
|
| Placebo | Placebo Comparator | Subjects took placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D | Dietary Supplement | Subjects took vitamin D or placebo |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zuomin Wang, Doctor | Dean of Stomatology Department | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2000IU/Day | Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo |
| FG001 | 1000IU/Day | Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo |
| FG002 | Placebo | Subjects took placebo vitamin D: Subjects took vitamin D or placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 2000IU/Day | Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo |
| BG001 | 1000IU/Day | Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm | at baseline |
|
Through study completion, an average of 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2000IU/Day | Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo |
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The observation time was short. Mechanical periodontal therapy might be too close in time to the vitamin D treatment. Did not adjust for possible confounding factors (e.g., dietary vitamin D) . The study was performed at one single center.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wang Zuomin | Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University | +86-010-85231492 | wzuomin@sina.cn |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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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 |
| BG002 | Placebo | Subjects took placebo vitamin D: Subjects took vitamin D or placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects took placebo vitamin D: Subjects took vitamin D or placebo |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mm | 3 months after periodontal treatment |
|
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | mm | 6 months after periodontal treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | at baseline |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 3 months after periodontal treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 6 months after periodontal treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | at baseline |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 3 months after periodontal treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 6 months after periodontal treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | at baseline |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months after periodontal treatment |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months after periodontal treatment |
|
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
| EG001 | 1000IU/Day | Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo | 0 | 120 | 0 | 120 | 0 | 120 |
| EG002 | Placebo | Subjects took placebo vitamin D: Subjects took vitamin D or placebo | 0 | 120 | 0 | 120 | 0 | 120 |
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| 0.041 |
| Superiority |
| 0.038 |
| Superiority |
| ANOVA |
| 0.073 |
| Superiority |
| ANOVA |
| 0.083 |
| Superiority |