Assessment of Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis
Condition: Menopause
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Neopterin is an early and valuable biomarker of cellular immunity, shown to be a sensitive
      assessment parameter for cell-mediated immune reactions. Hence determination of neopterin
      concentrations in distinctive body fluids is of diagnostic interest in a wide range of T
      lymphocytes and macrophages originated diseases. Increased neopterin production is also found
      in infections due to intracellular living bacteria and parasites. Neopterin concentration is
      directly proportional to the reactive oxygen species levels and is inversely related to the
      serum concentration of antioxidants like alpha-tocopherol. Hence it can be regarded as a
      marker of reactive oxygen species formed by the activated cellular immune system.
      Consequentially this is useful for predicting the prognosis and diagnosis of severe form of
      periodontal diseases. Menopause accomplishes a wide range of changes in women's body, and the
      oral cavity is also not exceptional. As exalted levels of ovarian hormones, detected in
      pregnancy and oral contraceptive usage, can lead to an increase of gingival inflammation. On
      the contrary, menopause shows depleted levels of ovarian sex steroids, which also causes
      worsening of gingival health. Post-menopause was found to be more aggressive and destructive
      in nature compared to pre-menopause. It has been assessed that the prevalence of oral
      discomfort was found to be significantly higher along with low flow rates of the saliva with
      the presence of periodontal disease more frequently. Studies demonstrated that non-surgical
      periodontal therapy reduces inflammation and improves periodontal status. Therefore it can be
      assumed that overall inflammatory markers also reduce after non-surgical periodontal therapy.
    

Detailed description: 
      A total of 30 patients will be selected, 15 per-menopause and 15 post-menopausal women. Full
      mouth scaling and root planing will be performed. All clinical parameters will be recorded at
      the baseline visit before mechanical debridement and after 3 months of treatment. Saliva
      samples will be collected at the primary visit before scaling and root planing as a baseline
      value, and after 1 month and 3 months postoperatively. Gingival crevicular fluid (GCF)
      samples will be collected at the primary visit before scaling and root planing as a baseline
      value, and after 1 month and 3 months postoperatively. Neopterin will be measured in the
      samples using commercially available Enzyme Linked Immunosorbent Assay (ELISA) kit.
      Statistical analysis will be performed to the results.
    

Intervention name(s): assessment of neopterin levels
Intervention type(s): Diagnostic Test
Intervention description(s): neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Periodontitis; Neopterin; Menopausal women; Non-surgical periodontal therapy