Effects of Vitamin D on Moderate to Severe Periodontitis
Primary Purpose
Chronic Peritonitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vitamin D
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Peritonitis focused on measuring Vitamin D
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
2000IU/day
1000IU/day
Placebo
Arm Description
Subjects took 2000IU vitamin D per day
Subjects took 1000IU vitamin D per day
Subjects took placebo
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03044886
First Posted
January 17, 2017
Last Updated
February 10, 2019
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03044886
Brief Title
Effects of Vitamin D on Moderate to Severe Periodontitis
Official Title
Effects of Vitamin D on Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Peritonitis
Keywords
Vitamin D
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2000IU/day
Arm Type
Experimental
Arm Description
Subjects took 2000IU vitamin D per day
Arm Title
1000IU/day
Arm Type
Experimental
Arm Description
Subjects took 1000IU vitamin D per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects took placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
Subjects took vitamin D or placebo
Primary Outcome Measure Information:
Title
Attachment Loss (AL)
Description
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
Title
Attachment Loss (AL)
Description
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
Title
Attachment Loss (AL)
Description
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
Secondary Outcome Measure Information:
Title
Probing Depth (PD)
Description
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
Title
Probing Depth (PD)
Description
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
Title
Probing Depth (PD)
Description
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
Title
Alveolar Crest Height (ACH)
Description
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
Title
Alveolar Crest Height (ACH)
Description
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
Title
Alveolar Crest Height (ACH)
Description
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
Title
Bleeding Index (BI)
Description
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
Title
Bleeding Index (BI)
Description
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
Title
Bleeding Index (BI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuomin Wang, Doctor
Organizational Affiliation
Dean of Stomatology Department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Vitamin D on Moderate to Severe Periodontitis
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