Clinical trial NCT03241381: Prevalence of Serum-Vitamin D Abnormalities, Periodontitis and Anaemia in Patients With Melasma
Official title: A Cross Sectional Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melasma, Periodontitis, Vitamin D Abnormalities, Anaemia
Keywords: observational sample
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total number of 100 patients participated in the study, 50 in each group. Patients visiting the Dept. of Oral medicine, with melasma on face within the age group of 30-70yrs in either gender were included in the study, matched with similar control group without melasma after obtaining informed consent.

Brief summary: Melasma is a commonly pigmention characterized by melanotic patches on the face. literature searched revealed that periodontitis and vitamin D deficiency have occurred along with anemia. Actinic associated factors may be indirectly related to vitamin D, melasma contributes to sun exposed area of face.To correlate melasma with clinical evidence of periodontitis and vitamin D serum analysis along side hb %. Patients with facial melasma between 30-70yrs of either gender formed Group A (95). Anaemia and periodontitis were Clinically checked. Additionally serum analysis of vitamin D and hb percentage were analysed. Similar procedure was carried out on controls which had Group B (95) patients with no melasma on face.

The study revealed significant correlation between melasma and periodontitis with vitamin D abnormalities (p value\<.05), where as insignificant correlation between melasma and Hb%. The correlation between melasma, vitamin d changes and periodontitis may prompt the clinician to check for any such changes in any patient. Melasma in patients with periodontitis and serum vitamin D changes might be a considered as a syndrome.

Detailed description: Melasma, is a relatively common chronic pigmentation of the face, although it may be localized also on the neck and forearms. It is also called as chloasma or mask of pregnancy. It has higher prevalence in women and occurs less commonly in men. It most commonly affects the sun-exposed areas of skin of face. Three patterns of presentation have been reported: Centro-facial, malar and mandibular forms. The interplay of various risk factors are known to contribute in the pathogenesis of melasma such as genetic predisposition, ultraviolet radiation, hormonal factors, oral contraceptives and drugs like phenytoin. Thyroid abnormalities were reported to occur with melasma. Skin pigmentation is a common manifestation in nutritional deficiencies and frequently associated with deficiency of vitamin B12 . Increased iron may affect the pattern and course of pigmentation, however it is unclear how they coexist. Vitamin D3 (cholecalciferol) is synthesized from 7-dehydrocholesterol by photochemical process in the skin and through successive hydroxylation to its active metabolite. 1, 25-dihydroxyvitamin D3 \[1, 25(OH)2D3; calcitriol\] is formed in liver and kidney. Intracellular receptor (VDR) helps in binding of vitamin D which helps the epithelial cells and melanocytes a target for vitamin D. Although vitamin D is used in the treatment of melanoma and psoriasis and active role of 1, 25(OH)2D3 in skin no reports of melasma associated with vitamin D reported. The dysfunction of 1,25(OH)2D3 - VDR system may lead to periodontal disease . Mineral bone density could be directly related to deficiency of vitamin D which also progress to osteoporosis. Studies have reported that anemia may predispose to periodontitis but the correlation was not determined. Until date, no studies reported any correlation or mere association between melasma, periodontitis and serum vitamin D abnormalities as well as decreased Hb levels. The present study was intended to assess the presence of periodontitis and vitamin D deficiency in melasma patients and evaluate clinical presence of periodontitis, which may occur in conjunction with melasma and vitamin D deficiency. The mere presence of melasma may help to investigate for further oral issues such as periodontitis and anemia which may or may not be associated with vitamin D abnormalities.

Patients visiting the Dept. of Oral medicine, with melasma on face within the age group of 30-70yrs in either gender were included in the study, matched with similar control group without melasma after obtaining informed consent.

The patients were divided into 2 groups. Group A, had Patients with melasma in whom 2 ml of blood was collected for estimation of serum-vitamin D levels, and complete blood picture was estimated for Haemoglobin percentage and clinical oral examination was evaluated for periodontitis. Group B served as control arm, where same procedure of blood parameter estimation and clinical examination protocol was followed as in group A.

Total number of 100 patients participated in the study, 50 in each group. The samples that resulted out of recruitment were tabulated and appropriate statistical analysis was done comparing the both groups with the presence or absence of periodontitis and serum vitamin D abnormalities and serum Hb% levels.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were patients with history of melasma and who were willing to be part of the study and patients who were not on any Systemic medication.

Exclusion Criteria:

* Exclusion criteria included patients who were not willing to be part of the study, patients who had endocrine disorders, patients with generalized pigmentation and as well as patients on steroid therapy.

Primary outcomes:
measure: Serum Vitamin D analysis
timeFrame: 3 -4 days
measure: Serum- hemoglobin levels
timeFrame: 1 day
measure: Clinical Periodontal index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Panineeya Institute of dental sciences
name: NALLAN Ck CHAITANYA, mds
role: PRINCIPAL_INVESTIGATOR
References: