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Completed

NCT Number: NCT03044886

Effects of Vitamin D on Moderate to Severe Periodontitis

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.

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Key information

Conditions

Chronic Peritonitis

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Dietary Supplement

Subjects took vitamin D or placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

Effects of Vitamin D on Chronic Periodontitis

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2017
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.