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Vit D Journal Presentation


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Vit D Journal Presentation

  2. 2. This trial aimed to evaluate the efficacy and safety of vitamin D supplementation on the residual moderate and deep pockets following nonsurgical periodontal therapy.
  3. 3.  Periodontitis is one of the most common chronic inflammatory diseases with an overall prevalence ranging from 10% to 90% in adults.  If untreated, periodontitis may lead to loss of teeth and ultimately result in edentulism, which has been shown to have a negative impact on an individual's quality of life.  Vitamin D is classified as a secosteroid in which one of the rings has been broken by ultraviolet B (UVB) sunlight and the main source of vitamin D is de novo synthesis in the skin.  It is well known for its role in calcium homeostasis by promoting calcium absorption in the intestine and stimulating osteoblasts to enable normal bone growth and preservation.
  4. 4. RATIONALE OF THE STUDY VITAMIN D AND PERIODONTAL HEALTH  More recent studies showed significant associations between periodontal health and intake of vitamin D and calcium, and that dietary supplementation with calcium and vitamin D may improve periodontal health, increase bone mineral density in the mandible and inhibit alveolar bone resorption.  In a recently published longitudinal study, Garcia et al reported that calcium and vitamin D supplementation may reduce the severity of periodontal disease if used at doses higher than 800- 1,000 IU daily and supported the rational for testing the potential beneficial role of vitamin D on periodontal disease in randomized clinical trials.
  5. 5.  They also noted that vitamin D, in addition to its role in bone and calcium homeostasis, acts as an anti-inflammatory agent because it inhibits immune cell cytokine expression and causes monocyte/macrophages to secrete molecules that have a strong antibiotic effect. Indeed, vitamin D deficiency may be linked to increased risk of infectious diseases.  This suggests that vitamin D may be of benefit in the treatment of periodontitis, not only because of its direct effects on bone metabolism, but also because it may have antibiotic effects on periodontopathogens and inhibit inflammatory mediators that contribute to the periodontal destruction.
  6. 6.  Recent research indicates that with the help of certain enzymes, gingival epithelial cells can convert inactive vitamin D (Vitamin D3) to the active form (25(OH)D) in situ, which could have local effect on periodontal tissue directly.  Menzel LP et al reported that treatment of gingival epithelial cells with 25(OH)D inhibited the intracellular growth of P gingivalis.  Topical application of both vitamin D3 and 25(OH)D to the gingiva of mice led to rapid inhibition of IL-1α expression, a prominent pro-inflammatory cytokine associated with inflammation.
  7. 7.  Liu K et al found that 25(OH)D concentrations in gingival crevicular fluid were 300 times higher than those in the plasma of patients with aggressive periodontitis.  Several observational studies reported that vitamin D levels were inversely associated with gingivitis and periodontitis.  Additionally, vitamin D and calcium supplementation had a modest positive effect on periodontal health.
  8. 8. STUDY DESIGN  This study was a one-center, randomized placebo-controlled, double-blind parallel trial with 3 months of follow-up.  This study design included a pre-study phase of 3-month clinical examination to screen patients and 3 months of interventional period.  Patients with chronic periodontitis were screened and recruited from the Department of Stomatology, Beijing Chao-Yang Hospital, Capital Medical University between December 2014 and June 2015.
  9. 9. After 3 months of periodontal examination. INCLUSION CRITERIA  Age between 30 and 70 years old.  More than 20 teeth remaining in the mouth.  Clinical diagnosis of moderate to severe periodontits.  Not receiving periodontal treatment within last 6 months.  Not taking antibiotic drugs within the previous 3 months. DIAGNOSTIC CRITERIA  For moderate to severe periodontitis. At least six sites for all teeth in the mouth with periodontal pocket depth more than 6 mm, attachment loss(AL) more than 4 mm. X-ray showing at least six sites with alveolar bone loss more than one third of the root length.
  10. 10. EXCLUSION CRITERIA  Diabetes, thyroid, or parathyroid endocrine-associated diseases.  Severe systemic diseases, such as cancer.  Taking vitamin D and/or calcium drugs during the pre-study phase.  Taking aspirin, non-steroidal anti-inflammatory drugs, or steroids.  Pregnant or preparing to become pregnant within the previous year.  Suffering from hypercalcemia and malabsorption syndrome. STUDY POPULATION The number of patients to be enrolled per group was calculated to be 99. However, taking into account a possible dropout rate of <20%, the final number of patients included in this trial was 120.
  11. 11. CLINICAL PROCEDURES  In the pre-study phase, patients‘ were collected with basic information, including age, sex, height, weight, smoking history, and preliminary periodontal status (eg, tartar, plaque, and stain).  All subjects were assigned to receive periodontal therapy including oral hygiene instruction, supragingival scaling, subgingival scaling, and root planing.
  12. 12. • Periodontal examinations were performed with Williams probe one week after supragingival scaling to record plaque index (PLI), probing depth (PD), bleeding index (BI), AL, tooth loss, and tooth mobility. •All patients received the same treatment procedures throughout the study. •After three months of nonsurgical periodontal therapy, clinical examination was performed to select eligible patients. •A total of 360 patients were randomly assigned to receive a pillpack containing 90 capsules of 2000 IU vitamin D3, 1000 IU vitamin D3, or placebo.
  13. 13.  Participants were instructed to take one capsule daily and not to provide any information to the study personnel about the treatment assignments.  During the periods of intervention, the subjects were followed up every month and asked to bring back the pillpacks.  Three months after the intervention, all subjects were followed up at clinical visits and underwent periodontal examinations.  If the patients’ PD measurements ≥6 mm during follow-up, periodontal surgery was suggested for those sites.
  14. 14.  The primary outcome measure was AL, and the secondary outcome measures included serum 25(OH)D levels, ACH, PD, BI, and PLI.  Serum 25(OH)D levels were measured by vitamin D Direct Elisa kit (Immunodiagnostic Systems Limited, IDS). To measure serum 25(OH)D levels, 3 mL venous blood samples were drawn by venipuncture after a 12-hours fast. After 1 hour coagulation, serum was centrifuged and stored at −20°C.  Examinations of PD and AL included six sites on each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual, and distal lingual.
  15. 15.  Panoramic radiographs derived from CBCT data were used to evaluate alveolar crest height (ACH).  The ACH is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.  BI was scored on a 0-5 scale when any visual evidence of bleeding was noted.  PLI was scored on a 0-3 scale based on the method promoted by Silness & Löe.
  16. 16. Statistical analysis  The normality of data distribution using the KolmogorovSmirnov goodness-of-fit test, and data were expressed as mean ± standard deviation (SD) for normally distributed continuous variables.  One-way analysis of variance (ANOVA) and NeumanKeuel test were carried out to determine difference between groups and changes during follow-up.
  17. 17.  The last observation carried forward (LOCF) approach was used to impute missing efficacy values.  All statistical analysis was performed using SPSS software (version17.0; SPSS Inc).  A P value of P < .05 was considered statistically significant.
  18. 18. RESULTS  Total of 360 randomized patients, 323 patients finished the therapy regime (vitamin D 2000 IU/d: n = 105; vitamin D 1000 IU/d: n = 110; placebo: n = 108). Thirty-seven patients withdrew, giving a dropout rate of 10.3%.  There was a slight but significant decrease in AL and PD in both vitamin D groups compared with placebo group for moderate and deep pockets.
  19. 19.  About 2000 IU/d vitamin D3 group, 1000 IU/d vitamin D3 group, and placebo group all decreased the AL for both moderate pockets (−0.4 mm vs −0.4 mm vs −0.3 mm) and deep pockets (−1.1 mm vs −1.1 mm vs −1.0 mm) (all P < .05). Similarly, PD was also decreased in these three groups for both moderate pockets and deep pockets (all P < .05). In addition, vitamin D supplementation was well tolerated, and no adverse events were reported.
  20. 20. Baseline characteristics Baseline characteristics of the participants 2000 IU/d vitamin D (n = 120) 1000 IU/d vitamin D (n = 120) Placebo (n = 120) P- value Age, mean (sd) 49 (5.4) 51 (6.3) 53 (5.2) 0.233 Gender, N (%) Male 59 (49.2) 62 (51.6) 57 (47.5) 0.548 Female 61 (50.8) 58 (48.4) 63 (52.5) 0.632 Smoking, N (%) Smoker 13 (10.8) 11 (9.2) 9 (7.5) 0.374 Non-smoker 96 (80.0) 102 (85.0) 99 (82.5) 0.628 Past smoker 11(9.2) 7 (5.8) 12 (10.0) 0.541
  21. 21. Treatment effects  After 3 months of vitamin D supplementation treatment, there was a dose-dependent decrease in the AL and PD for moderate and deep pockets.  Vitamin D 2000 IU/d and 1000 IU/d provided a reduction in AL, decreased 0.4 mm in both intervention groups on average, compared with 0.3 mm in placebo group for moderate pockets (P < .05); 1.1 mm in both intervention groups compared with 1.0 mm in placebo group for deep pockets (P < .05).
  22. 22.  PD was also significantly decreased: by 0.5 mm and 0.3 mm in vitamin D intervention groups and 0.2 mm in placebo groups for moderate pockets (P < .05); 0.6 mm and 0.5 mm in vitamin D intervention groups and 0.4 mm in placebo group for deep pockets (P < .05).  The differences between intervention and placebo groups were 0.3 mm and 0.1 mm for moderate pockets; 0.2 mm and 0.1 mm for deep pockets, which were also statistically significant although the magnitude was modest.  No significant difference in changes of ACH and BI was observed between treatment groups. Besides, the differences in mean changes of PLI were not significant among groups.
  23. 23. DISCUSSION  Vitamin D supplementation may improve periodontal health and may be used for treating moderate or severe periodontitis adjunctively, which is consistent with several previous studies.  Krall et al found that patients over 65 years old who received supplementation of 700 IU/d vitamin D and 500 mg/d calcium for 3 years lost fewer teeth than a placebo group.  Hiremath et al found a dose-dependent anti-inflammatory effect of vitamin D supplementation on gingivitis.  Vitamin D supplementation is safe and effective anti- inflammatory agent in doses ranging from 500 IU/d to 2000 IU/d, with an apparent earlier effect at the highest dose of 2000 IU per day.
  24. 24. CONCLUSION Although statistically significant differences were observed in favor to vitamin D supplementation, the magnitude of effect size tended to be modest with limited clinical relevance and the long- term efficacy and safety warrant further investigation.
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