Chronic Peritonitis
Conditions
Keywords
Vitamin D
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENTvitamin D
Subjects took vitamin D or placebo
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 30 years old to 70 years old 2. More than 20 teeth remaining in the mouth 3. Clinical diagnosis of moderate to severe periodontitis 4. Not receiving periodontal treatment within 6 months 5. Not taking antibiotic drugs within 3 months.
Exclusion criteria
1. Diabetes, thyroid and parathyroid endocrine associated diseases 2. Severe systemic diseases, such as cancer 3. Taking vitamin D and / or calcium drugs during observation 4. Taking aspirin, non-steroidal anti-inflammatory drugs, and steroids 5. Pregnant or prepare to pregnant within one year 6. Have been suffering from hypercalcemia, malabsorption syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attachment Loss (AL) | at baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth (PD) | at baseline | 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. |
| Alveolar Crest Height (ACH) | at baseline | 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. |
| Bleeding Index (BI) | at baseline | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2000IU/Day Subjects took 2000IU vitamin D per day
vitamin D: Subjects took vitamin D or placebo | 120 |
| 1000IU/Day Subjects took 1000IU vitamin D per day
vitamin D: Subjects took vitamin D or placebo | 120 |
| Placebo Subjects took placebo
vitamin D: Subjects took vitamin D or placebo | 120 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 10 | 12 |
Baseline characteristics
| Characteristic | 1000IU/Day | Placebo | 2000IU/Day | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 13 Participants | 17 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants | 107 Participants | 103 Participants | 320 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 6.3 | 53 years STANDARD_DEVIATION 5.2 | 49 years STANDARD_DEVIATION 5.4 | 51 years STANDARD_DEVIATION 5.3 |
| Region of Enrollment China | 120 participants | 120 participants | 120 participants | 360 participants |
| Sex: Female, Male Female | 62 Participants | 57 Participants | 59 Participants | 178 Participants |
| Sex: Female, Male Male | 58 Participants | 63 Participants | 61 Participants | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 120 | 0 / 120 |
| other Total, other adverse events | 0 / 120 | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 | 0 / 120 |
Outcome results
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.
Time frame: 3 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Attachment Loss (AL) | 3.5 mm | Standard Deviation 0.7 |
| 1000IU/Day | Attachment Loss (AL) | 3.6 mm | Standard Deviation 0.7 |
| Placebo | Attachment Loss (AL) | 3.6 mm | Standard Deviation 0.6 |
p-value: 0.489ANOVA
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.
Time frame: at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Attachment Loss (AL) | 4.7 mm | Standard Deviation 1.1 |
| 1000IU/Day | Attachment Loss (AL) | 4.8 mm | Standard Deviation 0.9 |
| Placebo | Attachment Loss (AL) | 4.8 mm | Standard Deviation 0.9 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: 0.576ANOVA
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
Time frame: 6 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Attachment Loss (AL) | 3.4 mm | Standard Deviation 0.6 |
| 1000IU/Day | Attachment Loss (AL) | 3.3 mm | Standard Deviation 0.6 |
| Placebo | Attachment Loss (AL) | 3.3 mm | Standard Deviation 0.7 |
p-value: 0.042ANOVA
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.p-value: 0.041ANOVA
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.
Time frame: 6 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Alveolar Crest Height (ACH) | 7.7 mm | Standard Deviation 2.3 |
| 1000IU/Day | Alveolar Crest Height (ACH) | 7.7 mm | Standard Deviation 2.2 |
| Placebo | Alveolar Crest Height (ACH) | 7.7 mm | Standard Deviation 2 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: <0.05ANOVA
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.p-value: 0.073ANOVA
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.
Time frame: at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Alveolar Crest Height (ACH) | 7.7 mm | Standard Deviation 2.3 |
| 1000IU/Day | Alveolar Crest Height (ACH) | 7.7 mm | Standard Deviation 2.2 |
| Placebo | Alveolar Crest Height (ACH) | 7.8 mm | Standard Deviation 2.4 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: 0.521ANOVA
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.
Time frame: 3 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Alveolar Crest Height (ACH) | 7.7 mm | Standard Deviation 2.1 |
| 1000IU/Day | Alveolar Crest Height (ACH) | 7.6 mm | Standard Deviation 2.3 |
| Placebo | Alveolar Crest Height (ACH) | 7.7 mm | Standard Deviation 2.1 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: 0.742ANOVA
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.
Time frame: 3 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Bleeding Index (BI) | 1.5 score on a scale | Standard Deviation 0.8 |
| 1000IU/Day | Bleeding Index (BI) | 1.7 score on a scale | Standard Deviation 0.6 |
| Placebo | Bleeding Index (BI) | 1.6 score on a scale | Standard Deviation 0.8 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: 0.685ANOVA
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.
Time frame: 6 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Bleeding Index (BI) | 0.9 score on a scale | Standard Deviation 0.3 |
| 1000IU/Day | Bleeding Index (BI) | 1.2 score on a scale | Standard Deviation 0.7 |
| Placebo | Bleeding Index (BI) | 1.1 score on a scale | Standard Deviation 0.6 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.p-value: 0.083ANOVA
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: 0.075ANOVA
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.
Time frame: at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Bleeding Index (BI) | 3.5 score on a scale | Standard Deviation 1.1 |
| 1000IU/Day | Bleeding Index (BI) | 3.2 score on a scale | Standard Deviation 1.3 |
| Placebo | Bleeding Index (BI) | 3.8 score on a scale | Standard Deviation 1.2 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: 0.348ANOVA
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.
Time frame: 3 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Probing Depth (PD) | 2.5 mm | Standard Deviation 0.5 |
| 1000IU/Day | Probing Depth (PD) | 2.6 mm | Standard Deviation 0.4 |
| Placebo | Probing Depth (PD) | 2.6 mm | Standard Deviation 0.5 |
p-value: 0.34ANOVA
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.
Time frame: at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Probing Depth (PD) | 3.6 mm | Standard Deviation 0.8 |
| 1000IU/Day | Probing Depth (PD) | 3.7 mm | Standard Deviation 0.8 |
| Placebo | Probing Depth (PD) | 3.6 mm | Standard Deviation 0.7 |
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.p-value: 0.71ANCOVA
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.
Time frame: 6 months after periodontal treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2000IU/Day | Probing Depth (PD) | 2.4 mm | Standard Deviation 0.5 |
| 1000IU/Day | Probing Depth (PD) | 2.5 mm | Standard Deviation 0.4 |
| Placebo | Probing Depth (PD) | 2.5 mm | Standard Deviation 0.4 |
p-value: 0.048ANOVA
Comparison: One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.p-value: 0.038ANOVA