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Effects of Vitamin D on Moderate to Severe Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044886
Recruitment Status : Completed
First Posted : February 7, 2017
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Zuo Min Wang, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Peritonitis Dietary Supplement: vitamin D Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Effects of Vitamin D on Chronic Periodontitis
Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: 2000IU/day
Subjects took 2000IU vitamin D per day
Dietary Supplement: vitamin D
Subjects took vitamin D or placebo

Experimental: 1000IU/day
Subjects took 1000IU vitamin D per day
Dietary Supplement: vitamin D
Subjects took vitamin D or placebo

Placebo Comparator: Placebo
Subjects took placebo
Dietary Supplement: vitamin D
Subjects took vitamin D or placebo




Primary Outcome Measures :
  1. Attachment Loss (AL) [ Time Frame: 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.

  2. Attachment Loss (AL) [ Time Frame: 3 months after periodontal treatment ]
    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. Attachment Loss (AL) [ Time Frame: 6 months after periodontal treatment ]
    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 :
  1. Probing Depth (PD) [ Time Frame: 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.

  2. Probing Depth (PD) [ Time Frame: 3 months after periodontal treatment ]
    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. Probing Depth (PD) [ Time Frame: 6 months after periodontal treatment ]
    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.

  4. Alveolar Crest Height (ACH) [ Time Frame: 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.

  5. Alveolar Crest Height (ACH) [ Time Frame: 3 months after periodontal treatment ]
    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. Alveolar Crest Height (ACH) [ Time Frame: 6 months after periodontal treatment ]
    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.

  7. Bleeding Index (BI) [ Time Frame: 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.

  8. Bleeding Index (BI) [ Time Frame: 3 months after periodontal treatment ]
    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.

  9. Bleeding Index (BI) [ Time Frame: 6 months after periodontal treatment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044886


Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: Zuomin Wang, Doctor Dean of Stomatology Department

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Responsible Party: Zuo Min Wang, Dean of Stomatology Department, Beijing Chao-Yang Hospital, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT03044886    
Other Study ID Numbers: BeijingCYH1
First Posted: February 7, 2017    Key Record Dates
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zuo Min Wang, Beijing Chao Yang Hospital:
Vitamin D
Additional relevant MeSH terms:
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Peritonitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents