Effects of Vitamin D on Moderate to Severe Periodontitis

Chronic Peritonitis Clinical Trial

Official title:

Effects of Vitamin D on Chronic Periodontitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044886
• Other study ID #: BeijingCYH1
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2019
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Peritonitis
• Periodontitis
• Peritonitis

Intervention

Dietary Supplement:
• vitamin D
Subjects took vitamin D or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	at baseline
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.	3 months after periodontal treatment
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	6 months after periodontal treatment
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.	at baseline
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.	3 months after periodontal treatment
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.	6 months after periodontal treatment
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.	at baseline
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.	3 months after periodontal treatment
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.	6 months after periodontal treatment
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.	at baseline
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.	3 months after periodontal treatment
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.	6 months after periodontal treatment