Prevalence of Serum-Vitamin D Abnormalities, Periodontitis and Anaemia in Patients With Melasma

NCT03241381 | Completed DMC

• 1 other identifier: ECR/267/Indt/AP/2016
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Melasma, Periodontitis, Vitamin D Abnormalities, Anaemia

Keywords

observational sample

Outcome Measures

Primary Outcomes (3)

• Serum Vitamin D analysis

  I. The criteria for serum vitamin D analysis was followed which was laid by NATIONAL INSTITUTE OF HEALTH vitamin D fact sheet (2011) in both the groups using chemilumnescence method. \<12 ng/ml -significant deficiency 12- 20 ng/ml - insufficiency \>20 ng/ml - normal \> 50 ng/ml - hypervitaminosis

  3 -4 days

• Serum- hemoglobin levels

  Evidence of pallor was checked clinically by examination of palpebral conjunctiva and correlated with serum haemoglobin percentage in both the groups using photometry method.

  1 day

• Clinical Periodontal index

  The criteria to diagnose periodontitis clinically was followed by regulations laid down by Russell's periodontal index status , using mouth mirror and plain probe on all the gingival tissue circumscribing each tooth. It was assessed for gingival inflammation and periodontal involvement with loss of attachment. The evaluation was done by only one specialist.

  1 day

Study Arms (2)

Group A : Melasma

patients with facial pigmentation in the form of melasma

Diagnostic Test: vitamin D serum assay study and control groups; Diagnostic Test: Photometry; Other: Russels periodontal index

Group B: Non Melasma

Patients without any facial pigmentation or melasma

Diagnostic Test: vitamin D serum assay study and control groups; Diagnostic Test: Photometry; Other: Russels periodontal index

Interventions

vitamin D serum assay study and control groups DIAGNOSTIC_TEST

Serum- vitamin D assay

Group A : Melasma; Group B: Non Melasma

Photometry DIAGNOSTIC_TEST

Serum- Hemoglobin assay

Group A : Melasma; Group B: Non Melasma

Russels periodontal index OTHER

Clinical examination for periodontitis

Group A : Melasma; Group B: Non Melasma

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

MeSH Terms

Conditions

Melanosis; Periodontitis; Anemia

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• NALLAN Ck CHAITANYA, mds

  Panineeya Institute of dental sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, department of oral medicine and radiology

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share