Effects of Vitamin D on Moderate to Severe Periodontitis

Effects of Vitamin D on Chronic 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.

Study Overview

• Status: Completed
• Conditions: Chronic Peritonitis
• Intervention / Treatment: Dietary supplement: vitamin D

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).

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: Zuomin Wang, Doctor, Dean of Stomatology Department

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Vitamin D
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Intraabdominal Infections; Periodontitis; Peritonitis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: BeijingCYH1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No