search
Back to results

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
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Peritonitis focused on measuring Vitamin D

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 17, 2017
    Last Updated
    February 10, 2019
    Sponsor
    Beijing Chao Yang Hospital
    search

    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

    Learn more about this trial

    Effects of Vitamin D on Moderate to Severe Periodontitis

    We'll reach out to this number within 24 hrs